x
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Ireland
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98-1088325
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification No.)
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Title of each class
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Name of each exchange on which registered
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Ordinary shares, par value $0.20 per share
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New York Stock Exchange
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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Emerging growth company
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o
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Item 1.
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Business.
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•
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Specialty Brands includes innovative specialty pharmaceutical brands; and
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•
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Specialty Generics and Amitiza includes niche specialty generic drug products, APIs and Amitiza.
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H.P. Acthar® Gel (repository corticotropin injection) ("H.P. Acthar Gel") is an injectable drug approved by the U.S. Federal Drug Administration ("FDA") for use in 19 indications. The product currently generates substantially all of its net sales from ten of the on-label indications, including adjunctive therapy for short-term administration for an acute episode or exacerbation in rheumatoid arthritis ("RA"), including juvenile RA; monotherapy for the treatment of infantile spasms in infants and children under 2 years of age; treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus; treatment of acute exacerbations of multiple sclerosis ("MS") in adults; including a diuresis or a remission of proteinuria in nephrotic syndrome ("NS") without uremia of the idiopathic type or that due to lupus; treatment during an exacerbation or as maintenance therapy in selected cases of systemic dermatomyositis (polymyositis); treatment of symptomatic sarcoidosis; and treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa including uveitis. We may initiate commercial efforts for other approved indications where there is high unmet medical need. The currently approved indications of H.P. Acthar Gel are not subject to patent or other exclusivity.
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•
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Inomax® (nitric oxide) gas, for inhalation ("Inomax") is a vasodilator that, in conjunction with ventilatory support and other appropriate agents, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks) neonates with hypoxic respiratory failure ("HRF") associated with clinical or echocardiographic evidence of pulmonary hypertension. Inomax is marketed as part of the Inomax Total Care Package, which includes the drug product, proprietary drug-delivery systems, technical and clinical assistance, 24/7/365 customer service, emergency supply and delivery and on-site training. The Inomax Total Care Package maintains a number of patents, the latest of which expire in 2034, that contain claims to nitric oxide delivery systems expressly required by the drug labeling for administration of Inomax, covering a number of important functions, including patient safety and product performance features. Development continues for the next-generation Inomax device which will offer a compact, portable design that we believe will further enhance the safety of the product, as well as the simplicity and flexibility of use in a number of settings. There has been recent patent litigation related to the Inomax product, as further described in Note 20 of the Notes to the Consolidated Financial Statements included within Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K.
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•
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Ofirmev® (acetaminophen) injection ("Ofirmev") is a proprietary intravenous formulation of acetaminophen indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever. This product is marketed to hospitals and ambulatory surgical centers and provides us with an expanded presence in these channels. Ofirmev is protected by two patents listed in the Orange Book: Approved Drug Products with Therapeutic Equivalence ("the Orange Book"), one of which expired in August 2017 and the other will expire in June 2021. Settlement agreements have been reached in association with certain challenges to these patents, which allow for generic competition to Ofirmev in December 2020, or earlier under certain circumstances.
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Therakos® photopheresis ("Therakos") is focused on providing innovative immunotherapy treatment platforms that enhance the ability of a patient's immune system to fight disease. Therakos is the global leader in autologous immunotherapy delivered through extracorporeal photopheresis ("ECP") and provides the only integrated ECP system in the world. ECP involves drawing blood from the patient, separating white blood cells from plasma and red blood cells which are returned to the patient, and treating the white blood cells with an Ultraviolet-A ("UVA") light activated drug. The treated white blood cells are immediately re-administered back into the patient. ECP is approved by the FDA for use in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (“CTCL”) that is unresponsive to other forms of treatment. Outside the U.S., ECP is approved to treat several other serious diseases that arise from immune system imbalances. Therakos’ product suite, which is sold to hospitals, clinics, academic centers and blood banks, includes an installed system, a disposable procedural kit used for each treatment and a drug, UVADEX® (methoxsalen) Sterile Solution (“UVADEX”), as well as instrument accessories and instrument maintenance and repair services.
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Pipeline products - We have multiple products in various stages of development, which we believe will provide long-term organic growth and diversification. The status of each of these products is shown below. For a more detailed description of these pipeline products, refer to the Research and Development ("R&D") section in this Item 1. Business.
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hydrocodone (API) and hydrocodone-containing tablets;
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oxycodone (API) and oxycodone-containing tablets;
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acetaminophen (API) products;
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other controlled substances; and
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Amitiza.
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Terlipressin is being investigated for the treatment of hepatorenal syndrome ("HRS") type 1, an acute, rare and life-threatening condition requiring hospitalization, with no currently approved therapy in the U.S. or Canada. During fiscal 2018 we achieved more than 75% of our total enrollment for the ongoing Phase 3 clinical study to evaluate the efficacy and safety of terlipressin (for injection) in subjects with HRS type 1. This Phase 3 clinical study is being conducted under an FDA Special Protocol Assessment. We continue to make progress on this clinical study as we proceed to full enrollment. Results of a pooled analysis of clinical trial data suggests that treatment with Terlipressin is particularly beneficial for patients with HRS type 1 and low Mean Arterial Pressure. We expect the Phase 3 study for HRS type 1 to be completed by the second half of 2019. We anticipate being able to submit the new drug application ("NDA") filing to the FDA in 2020. We also expect to complete a second Phase 3 study for this development product.
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StrataGraft regenerative skin tissue is an investigational product in Phase 3 development for treatment of severe, deep partial thickness burns and Phase 2 development for treatment of severe, full thickness burns. In 2012, the FDA granted StrataGraft orphan product status, conferring seven years exclusivity to be applied upon approval of the drug. The product is being developed as a biologic to be filed under a biologic license application that would confer regulatory protection until 2032. In June 2017, we announced the enrollment of the first patient in our Phase 3 clinical study to evaluate the efficacy and safety of StrataGraft regenerative skin tissue in the promotion of autologous skin regeneration of complex skin defects due to thermal
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Stannsoporfin, a heme oxygenase inhibitor, is under investigation for its potential to reduce the production of bilirubin. If approved, stannsoporfin is expected to be a highly effective therapy used for near- and full-term infants at risk of developing complications associated with severe jaundice. This new treatment option may reduce the number of newborns advancing to bilirubin levels requiring more intrusive, less specific therapies, most often blood exchange transfusion and less frequently intravenous immunoglobululin infusions, both of which have a more complex and lengthy administration than stannsoporfin's single injection. Stannsoporfin, if approved, may also decrease the risks associated with other treatments (i.e., bilirubin rebound) and the risk of prolonged and/or severe bilirubin elevation, which can impact central nervous system development. In December 2016, stannsoporfin was granted fast track designation by the FDA.
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Xenon gas for inhalation is a noble gas that has been used safely as an inhaled therapy in several studies to date. Following cardiac arrest, calcium channels in the brain can get over-activated, causing neuronal damage and cell death. When inhaled, xenon binds to N-methyl-D-aspartate receptors through a unique glycine-binding mechanism and can help regulate the flow of ions through the calcium channels. By mitigating neuronal damage and cell death following a cardiac arrest, inhaled xenon may be able to reduce time in coma, lower mortality rates and improve cognitive and motor functions. The Phase 3 trial was granted FDA fast track designation in August 2018. The trial is being conducted under an FDA Special Protocol Agreement and the first patient was enrolled in December 2018.
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MNK-6105 (IV) and MNK-6106 (oral), an ammonia scavenger, is being studied for treatment of hepatic encephalopathy ("HE"), a neuropsychiatric syndrome associated with hyperammonemia, a complication of acute or chronic liver disease. If approved, MNK-6105 and MNK-6106 are expected to be effective therapy formulations that rapidly eliminate ammonia in the bloodstream, excreting it through the kidneys, a more effective and less burdensome method of addressing HE than existing treatment options. The intravenous ("IV") formulation of MNK-6105, if approved, is expected to provide rapid reduction in symptoms of acute HE, and potentially reduce hospitalization stay. MNK-6106's oral formulation, if approved, is expected to provide post-discharge continuity of care for the HE patient, reducing the risk of recurrent HE episodes and rehospitalization. It is also anticipated that patients may transition from the IV to the oral formulation prior to discharge from the hospital setting. The FDA and European Medicines Agency ("EMA") have granted orphan drug designation to MNK-6105/6106. The FDA also granted fast track designation to MNK-6105/6106. We are currently working with the FDA to initiate the Phase 3 trial for this development product.
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VTS-270 is in Phase 3 development for Niemann-Pick Type C ("NPC"). NPC is a complicated, ultra-rare neurodegenerative disease that typically presents in childhood and is ultimately fatal. NPC is caused by mutations in either the NPC1 or NPC2 genes, resulting in the disruption of the trafficking of intracellular cholesterol, leading to intracellular lipid accumulation in various tissues, including the brain, liver, and spleen. NPC presents with neurologic and visceral features that overlap with other diseases often leading to a missed or delayed diagnosis. Manifestations of the genetic disorder typically occur in
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CPP-1X/sulindac is in Phase 3 development for Familial Adenomatous Polyposis ("FAP") under a collaborative agreement with Cancer Prevention Pharmaceuticals ("CPP"). FAP results from a genetic mutation leading to uncontrolled growth of hundreds to thousands of polyps in the lower digestive tract. Left untreated, there is a high likelihood of developing colorectal cancer. The disease typically progresses without clear warning signs until reaching advanced stages. It can also lead to abnormal manifestations in other organs including bone, skin, retina, teeth and other malignant lesions. The FDA granted CPP-1X/sulindac its orphan drug designation, as well as its Fast Track designation, a process designed to facilitate development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Orphan drug status was also granted to the therapy by the EMA. CPP-1X/sulindac, if approved, will target the underlying disease mechanism, preventing polyp growth and delaying disease progression.
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Completion of formulation and laboratory testing in accordance with GLP that fully characterizes the drug product from a pre-clinical perspective and provides preliminary evidence that the drug product is safe to test in human beings;
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Filing an Investigational New Drug Application with the FDA will permit the conduct of clinical trials (testing in human beings under adequate and well-controlled conditions);
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Designing and conducting clinical trials to show the safety and efficacy of the drug product in accordance with GCP;
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Submitting the NDA for FDA review, which provides a complete characterization of the drug product;
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Satisfactory completion of FDA pre-approval inspections regarding the conduct of the clinical trials and the manufacturing processes at the designated facility in accordance with cGMP;
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If applicable, satisfactory completion of an FDA Advisory Committee meeting in which the FDA requests help from outside experts in evaluating the NDA;
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Final FDA approval of the full prescribing information, labeling and packaging of the drug product; and
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Ongoing monitoring and reporting of adverse events related to the drug product, implementation of a REMS program, if applicable, and conduct of any required Phase 4 studies.
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Phase 1 trials are typically small (less than 100 healthy volunteers) and are designed to determine the toxicity and maximum safe dose of the drug product.
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Phase 2 trials usually involve 100 to 300 participants and are designed to determine whether the drug product produces any clinically significant effects in patients with the intended disease or condition. If the results of these trials show promise, then a larger Phase 3 trial may be conducted.
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Phase 3 trials are often multi-institution studies that involve a large number of participants and are designed to show efficacy. Phase 3 (and some Phase 2) trials are designed to be pivotal, or confirmatory trials. The goal of a pivotal trial is to establish the safety and efficacy of a drug product by eliminating biases and increasing statistical power.
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In some cases, the FDA requires Phase 4 trials, which are usually performed after the NDA has been approved. Such post-marketing surveillance is intended to obtain more information about the risks of harm, benefits and optimal use of the drug product by observing the results of the drug product in a large number of patients.
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Fiscal Year Ended
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Three Months Ended
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December 28, 2018
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December 29, 2017
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September 30, 2016
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December 30, 2016
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CuraScript, Inc.
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35
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%
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40
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%
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38
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%
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43
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%
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McKesson Corporation
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*
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*
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12
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%
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10
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%
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Name
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Age
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Title
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Mark Trudeau
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57
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President, Chief Executive Officer and Director
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Mark Casey
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55
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General Counsel
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Matthew Harbaugh
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48
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President, Specialty Generics
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George Kegler
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63
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Executive Vice President and Chief Financial Officer, Interim
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Hugh O'Neill
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55
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Executive Vice President and Chief Commercial Officer
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Steven Romano, MD
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59
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Executive Vice President and Chief Scientific Officer
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Dagmar Rosa-Björkeson
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55
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Chief Strategy and Corporate Development Officer
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Dr. Frank Scholz
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50
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Executive Vice President and Chief Operations and Digital Innovation Officer
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Karen Sheehy
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57
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Chief Compliance Officer
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Ian Watkins
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56
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Chief Human Resources Officer
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Item 1A.
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Risk Factors.
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developing, testing and manufacturing products in compliance with regulatory and quality standards in a timely manner;
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our ability to successfully engage with the FDA or other regulatory authorities as part of the approval process and to receive requisite regulatory approvals for such products in a timely manner, or at all;
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the availability, on commercially reasonable terms, of raw materials, including API and other key ingredients;
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developing, commercializing and launching a new product is time-consuming, costly and subject to numerous factors, including legal actions brought by our competitors, that may delay or prevent the development, commercialization and/or launch of new products;
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unanticipated costs;
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payment of prescription drug user fees to the FDA to defray the costs of review and approval of marketing applications for branded and generic drugs;
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•
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experiencing delays as a result of limited resources at the FDA or other regulatory authorities;
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changing review and approval policies and standards at the FDA or other regulatory authorities;
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potential delays in the commercialization of generic products by up to 30 months resulting from the listing of patents with the FDA;
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effective execution of the product launches in a manner that is consistent with expected timelines and anticipated costs; and
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identifying appropriate partners for distribution of our products, including any future over-the-counter commercialization opportunities, and negotiating contractual arrangements in a timely manner with commercially reasonable terms.
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our ability to increase market demand for products through our own marketing and support of our sales force;
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our ability to implement and maintain pricing and continue to maintain or increase market demand for these products;
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our ability to achieve hospital and other third-party payer formulary acceptance, and maintain reimbursement levels by third-party payers;
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our ability to maintain confidentiality of the proprietary know-how and trade secrets relating to H.P. Acthar Gel;
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our ability to maintain and defend the patent protection and regulatory exclusivity of Ofirmev and Inomax;
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our ability to continue to procure raw materials or finished goods, as applicable, for H.P. Acthar Gel, Ofirmev, Inomax and Therakos from internal and third-party manufacturers in sufficient quantities and at acceptable quality and pricing levels in order to meet commercial demand;
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our ability to maintain fees and discounts payable to the wholesalers and distributors and GPOs, at commercially reasonable levels;
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whether the DOJ or other third parties seek to challenge and are successful in challenging patents or patent-related settlement agreements or our sales and marketing practices;
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warnings or limitations that may be required to be added to FDA-approved labeling; and
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the occurrence of adverse side effects related to or emergence of new information related to the therapeutic efficacy of these products, and any resulting product liability claims or product recalls.
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the generation, storage, use and transportation of hazardous materials;
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emissions or discharges of substances into the environment;
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investigation and remediation of hazardous substances or materials at various sites;
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chemical constituents in products and end-of-life disposal, mandatory recycling and take-back programs; and
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the health and safety of our employees.
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potentially longer payment cycles and difficulties in enforcing agreements and collecting receivables through certain non-U.S. legal systems;
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•
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potential inability to sell products into certain countries given the delay of foreign governments in responding to changes in our U.S. business licensing;
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•
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political and economic instability, including the impact of the 2016 referendum by British voters to exit the E.U. (commonly known as Brexit) and the related uncertainties;
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•
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the unpredictability of U.S. trade policy, including Section 301 tariffs and U.S. trade relations with other countries, that may increase raw material cost or impact our ability to obtain the raw materials we need to manufacture our products and impact our ability to sell our products outside of the U.S.;
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•
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potentially adverse tax consequences, tariffs, customs charges, bureaucratic requirements and trade barriers;
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•
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difficulties and costs of staffing and managing our non-U.S. operations;
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•
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exposure to global economic conditions; and
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•
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exposure to potentially unfavorable movements in foreign currency exchange rates associated with international net sales and operating expense and intercompany debt financings.
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•
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making it more difficult for us to satisfy our obligations with respect to our debt;
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•
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limiting our ability to obtain additional financing in the future for working capital, capital expenditures, acquisitions or other corporate requirements;
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•
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requiring a substantial portion of our cash flows to be dedicated to debt service payments instead of other purposes, thereby reducing the amount of cash flows available for working capital, capital expenditures, acquisitions and other general corporate purposes;
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•
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limiting our ability to refinance our indebtedness on terms acceptable to us or at all;
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•
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placing us at a competitive disadvantage to other less leveraged competitors;
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•
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making us more vulnerable to economic downturns and limiting our ability to withstand competitive pressures;
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•
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limiting our flexibility in planning for and reacting to changes in the industry in which we compete; and
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•
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increasing our costs of borrowing.
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incur, assume or guarantee additional indebtedness;
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declare or pay dividends, make other distributions with respect to equity interests, or purchase or otherwise acquire or retire equity interests;
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make any principal payment on, or redeem or repurchase, subordinated debt;
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make loans, advances or other investments;
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sell or otherwise dispose of assets, including capital stock of subsidiaries;
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incur liens;
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enter into transactions with affiliates;
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•
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enter into sale and lease-back transactions; and
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•
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consolidate or merge with or into, or sell all or substantially all of our assets to, another person or entity.
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•
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limited in how we conduct our business;
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•
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unable to raise additional debt or equity financing to operate during general economic or business downturns; or
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unable to compete effectively, execute our growth strategy or take advantage of new business opportunities.
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•
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market reaction to our proposed spin-off of the Specialty Generics and Amitiza business;
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•
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actual or anticipated fluctuations in our results of operations;
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changes in earnings estimated by securities analysts or our ability to meet those estimates;
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perceived impacts to our results from acquisitions of products, license rights or businesses;
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the operating and share price performance of comparable companies;
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•
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actual or anticipated sales of our ordinary shares;
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•
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allegations by third parties (even if unsubstantiated) regarding our products or business practices;
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•
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publicity and media reports potentially negative about the company or its products/reputation;
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•
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new regulations or legislation in the U.S. relating to the development, sale or pricing of pharmaceuticals or medical devices;
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•
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political pressure to reduce the pricing of pharmaceuticals;
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•
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continued consolidation in pharmacy networks and among insurers that may further increase their competitive market power;
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•
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changes to the regulatory and legal environment in which we operate; and
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U.S. and worldwide economic conditions.
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•
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provisions of our articles of association which allow our Board of Directors to adopt a shareholder rights plan (commonly known as a "poison pill") upon such terms and conditions as the Board of Directors deems expedient and in the best interests of our company;
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•
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a provision of our articles of association which generally prohibits us from engaging in a business combination with an interested shareholder for a period of three years following the date the person became an interested shareholder, subject to certain exceptions;
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rules regarding how shareholders may present proposals or nominate directors for election at shareholder meetings;
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•
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the right of our Board of Directors to issue preferred shares without shareholder approval in certain circumstances, subject to applicable law; and
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the ability of our Board of Directors to fill vacancies on our Board of Directors in certain circumstances.
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•
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the ability of each company to focus on its own strategic and operational plans and capital structure;
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•
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an appropriate capital structure for each company;
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•
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a distinct investment identity allowing investors to evaluate the merits, performance and future prospects of us separately from the Specialty Generics and Amitiza business; and
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•
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more effective equity-based compensation and currency for acquisitions.
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Item 1B.
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Unresolved Staff Comments.
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Item 2.
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Properties.
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Item 3.
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Legal Proceedings.
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Item 4.
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Mine Safety Disclosures.
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Item 5.
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Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
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Period
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|
Total Number of Shares Purchased
|
|
Average Price Paid per Share
|
|
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
|
|
Maximum Approximate Dollar Value of Shares that May Yet Be Purchased Under The Plans or Programs (in millions)
|
||||||
9/29/2018 - 10/26/2018
|
|
116
|
|
|
$
|
29.59
|
|
|
—
|
|
|
$
|
564.2
|
|
10/27/2018 - 11/30/2018
|
|
818
|
|
|
27.37
|
|
|
—
|
|
|
564.2
|
|
||
12/1/2018 - 12/28/2018
|
|
—
|
|
|
—
|
|
|
—
|
|
|
564.2
|
|
||
9/29/2018 - 12/28/2018
|
|
934
|
|
|
27.65
|
|
|
|
|
|
Item 6.
|
Selected Financial Data.
|
(in millions, except per share data)
|
Fiscal Year Ended (1), (2)
|
|
Three Months Ended (2)
|
||||||||||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
September 25, 2015
|
|
September 26, 2014
|
|
December 30, 2016
|
||||||||||||
|
|
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|
|
|
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|
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|
||||||||||||
Consolidated and Combined Statement of Income Data:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Net sales
|
$
|
3,215.6
|
|
|
$
|
3,221.6
|
|
|
$
|
3,380.8
|
|
|
$
|
2,923.1
|
|
|
$
|
1,650.3
|
|
|
$
|
829.9
|
|
Gross profit
|
1,471.2
|
|
|
1,657.5
|
|
|
1,857.6
|
|
|
1,624.4
|
|
|
884.5
|
|
|
446.7
|
|
||||||
Research and development expenses
|
361.1
|
|
|
276.9
|
|
|
261.2
|
|
|
202.7
|
|
|
140.5
|
|
|
66.1
|
|
||||||
Operating (loss) income
|
(3,720.9
|
)
|
|
492.9
|
|
|
633.1
|
|
|
362.4
|
|
|
42.9
|
|
|
(158.6
|
)
|
||||||
(Loss) income from continuing operations before income taxes
|
(4,052.0
|
)
|
|
61.6
|
|
|
233.4
|
|
|
107.3
|
|
|
(34.6
|
)
|
|
(298.5
|
)
|
||||||
Loss (income) from continuing operations
|
(3,621.9
|
)
|
|
1,771.2
|
|
|
489.0
|
|
|
236.6
|
|
|
(22.0
|
)
|
|
(176.8
|
)
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Share Data:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Basic (loss) income from continuing operations per share
|
$
|
(43.12
|
)
|
|
$
|
18.13
|
|
|
$
|
4.42
|
|
|
$
|
2.03
|
|
|
$
|
(0.34
|
)
|
|
$
|
(1.67
|
)
|
Diluted (loss) income from continuing operations per share
|
(43.12
|
)
|
|
18.09
|
|
|
4.39
|
|
|
2.00
|
|
|
(0.34
|
)
|
|
(1.67
|
)
|
||||||
Cash dividends per ordinary share
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Total assets
|
$
|
10,877.3
|
|
|
$
|
15,280.9
|
|
|
$
|
15,498.7
|
|
|
$
|
16,404.1
|
|
|
$
|
12,787.3
|
|
|
$
|
15,206.3
|
|
Long-term debt
|
6,069.2
|
|
|
6,420.9
|
|
|
5,788.7
|
|
|
6,474.3
|
|
|
3,874.0
|
|
|
5,880.8
|
|
||||||
Shareholders' equity
|
2,887.3
|
|
|
6,522.0
|
|
|
5,270.7
|
|
|
5,311.2
|
|
|
4,958.0
|
|
|
4,984.3
|
|
(1)
|
Fiscal 2016 included 53 weeks. All other fiscal years presented include 52 weeks. Refer to the Consolidated Financial Statements included within Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K for detail on our change in fiscal year, as well as trends in financial condition and results of operations for the fiscal years ended December 28, 2018, December 29, 2017 and September 30, 2016 and the three months ended December 30, 2016.
|
(2)
|
Financial data for all periods has been adjusted to reflect our change in accounting for pension and postretirement costs with the adoption of Accounting Standard Update ("ASU") 2017-07. See Note 4 of the Notes to Consolidated Financial Statements included within Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K.
|
Item 7.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations.
|
•
|
Specialty Brands includes innovative specialty pharmaceutical brands; and
|
•
|
Specialty Generics and Amitiza includes niche specialty generic drug products, APIs and Amitiza.
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
Percentage
Change |
|||||
U.S.
|
$
|
2,834.5
|
|
|
$
|
2,899.0
|
|
|
(2.2
|
)%
|
Europe, Middle East and Africa
|
256.8
|
|
|
242.3
|
|
|
6.0
|
|
||
Other
|
124.3
|
|
|
80.3
|
|
|
54.8
|
|
||
Net sales
|
$
|
3,215.6
|
|
|
$
|
3,221.6
|
|
|
(0.2
|
)
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 29, 2017
|
|
September 30, 2016
|
|
Percentage
Change
|
|||||
U.S.
|
$
|
2,899.0
|
|
|
$
|
3,095.4
|
|
|
(6.3
|
)%
|
Europe, Middle East and Africa
|
242.3
|
|
|
211.8
|
|
|
14.4
|
|
||
Other
|
80.3
|
|
|
73.6
|
|
|
9.1
|
|
||
Net sales
|
$
|
3,221.6
|
|
|
$
|
3,380.8
|
|
|
(4.7
|
)
|
|
Three Months Ended
|
|
|
|||||||
|
December 30, 2016
|
|
December 25, 2015
|
|
Percentage
Change
|
|||||
U.S.
|
$
|
763.7
|
|
|
$
|
740.2
|
|
|
3.2
|
%
|
Europe, Middle East and Africa
|
52.8
|
|
|
49.3
|
|
|
7.1
|
|
||
Other
|
13.4
|
|
|
21.7
|
|
|
(38.2
|
)
|
||
Net sales
|
$
|
829.9
|
|
|
$
|
811.2
|
|
|
2.3
|
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
Percentage
Change
|
|||||
Specialty Brands
|
$
|
2,306.2
|
|
|
$
|
2,352.0
|
|
|
(1.9
|
)%
|
Specialty Generics and Amitiza
|
909.4
|
|
|
869.6
|
|
|
4.6
|
|
||
Net sales
|
$
|
3,215.6
|
|
|
$
|
3,221.6
|
|
|
(0.2
|
)
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
Percentage
Change
|
|||||
U.S.
|
$
|
2,165.4
|
|
|
$
|
2,216.9
|
|
|
(2.3
|
)%
|
Europe, Middle East and Africa
|
79.8
|
|
|
73.0
|
|
|
9.3
|
|
||
Other
|
61.0
|
|
|
62.1
|
|
|
(1.8
|
)
|
||
Net sales
|
$
|
2,306.2
|
|
|
$
|
2,352.0
|
|
|
(1.9
|
)
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
Percentage Change
|
|||||
H.P. Acthar Gel
|
$
|
1,110.1
|
|
|
$
|
1,195.1
|
|
|
(7.1
|
)%
|
Inomax
|
542.7
|
|
|
505.2
|
|
|
7.4
|
|
||
Ofirmev
|
341.9
|
|
|
302.5
|
|
|
13.0
|
|
||
Therakos
|
231.2
|
|
|
214.9
|
|
|
7.6
|
|
||
BioVectra
|
53.1
|
|
|
54.7
|
|
|
(2.9
|
)
|
||
Other
|
27.2
|
|
|
79.6
|
|
|
(65.8
|
)
|
||
Specialty Brands
|
$
|
2,306.2
|
|
|
$
|
2,352.0
|
|
|
(1.9
|
)
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
Percentage
Change
|
|||||
U.S.
|
$
|
669.1
|
|
|
$
|
682.1
|
|
|
(1.9
|
)%
|
Europe, Middle East and Africa
|
177.0
|
|
|
169.3
|
|
|
4.5
|
|
||
Other
|
63.3
|
|
|
18.2
|
|
|
247.8
|
|
||
Net sales
|
$
|
909.4
|
|
|
$
|
869.6
|
|
|
4.6
|
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
Percentage Change
|
|||||
Hydrocodone (API) and hydrocodone-containing tablets
|
$
|
65.9
|
|
|
$
|
85.3
|
|
|
(22.7
|
)%
|
Oxycodone (API) and oxycodone-containing tablets
|
66.1
|
|
|
88.0
|
|
|
(24.9
|
)
|
||
Acetaminophen (API)
|
192.7
|
|
|
185.5
|
|
|
3.9
|
|
||
Amitiza
|
183.8
|
|
|
—
|
|
|
—
|
|
||
Other controlled substances
|
343.8
|
|
|
412.0
|
|
|
(16.6
|
)
|
||
Other
|
57.1
|
|
|
98.8
|
|
|
(42.2
|
)
|
||
Specialty Generics and Amitiza
|
$
|
909.4
|
|
|
$
|
869.6
|
|
|
4.6
|
|
|
Fiscal Year Ended
|
||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
||||||||
Specialty Brands
|
$
|
1,077.4
|
|
46.7
|
%
|
|
$
|
1,146.3
|
|
48.7
|
%
|
Specialty Generics and Amitiza (1)
|
105.0
|
|
11.5
|
|
|
266.4
|
|
30.6
|
|
||
Segment operating income
|
1,182.4
|
|
36.8
|
|
|
1,412.7
|
|
43.9
|
|
||
Unallocated amounts:
|
|
|
|
|
|
||||||
Corporate and allocated expenses
|
(155.8
|
)
|
|
|
(125.2
|
)
|
|
||||
Intangible asset amortization
|
(740.2
|
)
|
|
|
(694.5
|
)
|
|
||||
Restructuring and related charges, net (2)
|
(108.2
|
)
|
|
|
(36.4
|
)
|
|
||||
Non-restructuring impairment charges
|
(3,893.1
|
)
|
|
|
(63.7
|
)
|
|
||||
Separation costs
|
(6.0
|
)
|
|
|
—
|
|
|
||||
Total operating (loss) income
|
$
|
(3,720.9
|
)
|
|
|
$
|
492.9
|
|
|
(1)
|
Includes $118.8 million of inventory fair-value step up expense, primarily related to Amitiza during the fiscal year ended December 28, 2018.
|
(2)
|
Includes restructuring-related accelerated depreciation.
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 29, 2017
|
|
September 30, 2016
|
|
Percentage
Change
|
|||||
Specialty Brands
|
$
|
2,352.0
|
|
|
$
|
2,288.8
|
|
|
2.8
|
%
|
Specialty Generics and Amitiza
|
869.6
|
|
|
1,092.0
|
|
|
(20.4
|
)
|
||
Net sales
|
$
|
3,221.6
|
|
|
$
|
3,380.8
|
|
|
(4.7
|
)
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 29, 2017
|
|
September 30, 2016
|
|
Percentage
Change |
|||||
U.S.
|
$
|
2,216.9
|
|
|
$
|
2,163.6
|
|
|
2.5
|
%
|
Europe, Middle East and Africa
|
73.0
|
|
|
69.8
|
|
|
4.6
|
|
||
Other
|
62.1
|
|
|
55.4
|
|
|
12.1
|
|
||
Net sales
|
$
|
2,352.0
|
|
|
$
|
2,288.8
|
|
|
2.8
|
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 29, 2017
|
|
September 30, 2016
|
|
Percentage Change
|
|||||
H.P. Acthar Gel
|
$
|
1,195.1
|
|
|
$
|
1,160.4
|
|
|
3.0
|
%
|
Inomax
|
505.2
|
|
|
474.3
|
|
|
6.5
|
|
||
Ofirmev
|
302.5
|
|
|
284.3
|
|
|
6.4
|
|
||
Therakos
|
214.9
|
|
|
207.6
|
|
|
3.5
|
|
||
BioVectra
|
54.7
|
|
|
49.5
|
|
|
10.5
|
|
||
Other
|
79.6
|
|
|
112.7
|
|
|
(29.4
|
)
|
||
Specialty Brands
|
$
|
2,352.0
|
|
|
$
|
2,288.8
|
|
|
2.8
|
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 29, 2017
|
|
September 30, 2016
|
|
Percentage
Change
|
|||||
U.S.
|
$
|
682.1
|
|
|
$
|
931.8
|
|
|
(26.8
|
)%
|
Europe, Middle East and Africa
|
169.3
|
|
|
142.0
|
|
|
19.2
|
|
||
Other
|
18.2
|
|
|
18.2
|
|
|
—
|
|
||
Net sales
|
$
|
869.6
|
|
|
$
|
1,092.0
|
|
|
(20.4
|
)
|
|
Fiscal Year Ended
|
|
|
|||||||
|
December 29, 2017
|
|
September 30, 2016
|
|
Percentage Change
|
|||||
Hydrocodone (API) and hydrocodone-containing tablets
|
$
|
85.3
|
|
|
$
|
146.5
|
|
|
(41.8
|
)%
|
Oxycodone (API) and oxycodone-containing tablets
|
88.0
|
|
|
139.9
|
|
|
(37.1
|
)
|
||
Acetaminophen (API)
|
185.5
|
|
|
169.1
|
|
|
9.7
|
|
||
Other controlled substances
|
412.0
|
|
|
543.9
|
|
|
(24.3
|
)
|
||
Other
|
98.8
|
|
|
92.6
|
|
|
6.7
|
|
||
Specialty Generics and Amitiza
|
$
|
869.6
|
|
|
$
|
1,092.0
|
|
|
(20.4
|
)
|
|
Fiscal Year Ended
|
||||||||||
|
December 29, 2017
|
|
September 30, 2016
|
||||||||
Specialty Brands
|
$
|
1,146.3
|
|
48.7
|
%
|
|
$
|
1,060.7
|
|
46.3
|
%
|
Specialty Generics and Amitiza
|
266.4
|
|
30.6
|
|
|
444.7
|
|
40.7
|
|
||
Segment operating income
|
1,412.7
|
|
43.9
|
|
|
1,505.4
|
|
44.5
|
|
||
Unallocated amounts:
|
|
|
|
|
|
||||||
Corporate and allocated expenses
|
(125.2
|
)
|
|
|
(117.7
|
)
|
|
||||
Intangible asset amortization
|
(694.5
|
)
|
|
|
(700.1
|
)
|
|
||||
Restructuring and related charges, net (1)
|
(36.4
|
)
|
|
|
(37.6
|
)
|
|
||||
Non-restructuring impairment charges
|
(63.7
|
)
|
|
|
(16.9
|
)
|
|
||||
Total operating income
|
$
|
492.9
|
|
|
|
$
|
633.1
|
|
|
(1)
|
Includes restructuring-related accelerated depreciation.
|
|
Three Months Ended
|
|
|
|||||||
|
December 30, 2016
|
|
December 25, 2015
|
|
Percentage
Change
|
|||||
Specialty Brands
|
$
|
600.1
|
|
|
$
|
544.8
|
|
|
10.2
|
%
|
Specialty Generics and Amitiza
|
229.8
|
|
|
266.4
|
|
|
(13.7
|
)
|
||
Net sales
|
$
|
829.9
|
|
|
$
|
811.2
|
|
|
2.3
|
|
|
Three Months Ended
|
|
|
|||||||
|
December 30, 2016
|
|
December 25, 2015
|
|
Percentage
Change
|
|||||
U.S.
|
$
|
574.8
|
|
|
$
|
512.2
|
|
|
12.2
|
%
|
Europe, Middle East and Africa
|
16.2
|
|
|
17.0
|
|
|
(4.7
|
)
|
||
Other
|
9.1
|
|
|
15.6
|
|
|
(41.7
|
)
|
||
Net sales
|
$
|
600.1
|
|
|
$
|
544.8
|
|
|
10.2
|
|
|
Three Months Ended
|
|
|
|||||||
|
December 30, 2016
|
|
December 25, 2015
|
|
Percentage
Change |
|||||
H.P. Acthar Gel
|
$
|
325.4
|
|
|
$
|
286.7
|
|
|
13.5
|
%
|
Inomax
|
118.3
|
|
|
110.8
|
|
|
6.8
|
|
||
Ofirmev
|
72.5
|
|
|
66.9
|
|
|
8.4
|
|
||
Therakos
|
47.4
|
|
|
50.4
|
|
|
(6.0
|
)
|
||
BioVectra
|
7.4
|
|
|
14.2
|
|
|
(47.9
|
)
|
||
Other
|
29.1
|
|
|
15.8
|
|
|
84.2
|
|
||
Specialty Brands
|
$
|
600.1
|
|
|
$
|
544.8
|
|
|
10.2
|
|
|
Three Months Ended
|
|
|
|||||||
|
December 30, 2016
|
|
December 25, 2015
|
|
Percentage
Change
|
|||||
U.S.
|
$
|
188.9
|
|
|
$
|
228.0
|
|
|
(17.1
|
)%
|
Europe, Middle East and Africa
|
36.6
|
|
|
32.3
|
|
|
13.3
|
|
||
Other
|
4.3
|
|
|
6.1
|
|
|
(29.5
|
)
|
||
Net sales
|
$
|
229.8
|
|
|
$
|
266.4
|
|
|
(13.7
|
)
|
|
Three Months Ended
|
|
|
|||||||
|
December 30, 2016
|
|
December 25, 2015
|
|
Percentage
Change |
|||||
Hydrocodone (API) and hydrocodone-containing tablets
|
$
|
23.2
|
|
|
$
|
36.7
|
|
|
(36.8
|
)%
|
Oxycodone (API) and oxycodone-containing tablets
|
27.2
|
|
|
32.5
|
|
|
(16.3
|
)
|
||
Acetaminophen (API)
|
40.8
|
|
|
37.8
|
|
|
7.9
|
|
||
Other controlled substances
|
117.4
|
|
|
140.6
|
|
|
(16.5
|
)
|
||
Other
|
21.2
|
|
|
18.8
|
|
|
12.8
|
|
||
Specialty Generics and Amitiza
|
$
|
229.8
|
|
|
$
|
266.4
|
|
|
(13.7
|
)
|
|
Three Months Ended
|
||||||||||
|
December 30, 2016
|
|
December 25, 2015
|
||||||||
Specialty Brands
|
$
|
295.2
|
|
49.2
|
%
|
|
$
|
270.3
|
|
49.6
|
%
|
Specialty Generics and Amitiza
|
64.6
|
|
28.1
|
|
|
108.5
|
|
40.7
|
|
||
Segment operating income
|
359.8
|
|
43.4
|
|
|
378.8
|
|
46.7
|
|
||
Unallocated amounts:
|
|
|
|
|
|
||||||
Corporate and allocated expenses
|
(123.1
|
)
|
|
|
(37.2
|
)
|
|
||||
Intangible asset amortization
|
(175.7
|
)
|
|
|
(173.4
|
)
|
|
||||
Restructuring and related charges, net (1)
|
(5.3
|
)
|
|
|
(4.2
|
)
|
|
||||
Non-restructuring impairment charges
|
(214.3
|
)
|
|
|
—
|
|
|
||||
Total operating (loss) income
|
$
|
(158.6
|
)
|
|
|
$
|
164.0
|
|
|
(1)
|
Includes restructuring-related accelerated depreciation.
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||||||
|
December 28,
2018 |
|
December 29,
2017 |
|
September 30,
2016 |
|
December 30,
2016 |
|
December 25,
2015 |
||||||||||
Net cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
||||||||||
Operating activities
|
$
|
665.5
|
|
|
$
|
727.3
|
|
|
$
|
1,184.6
|
|
|
$
|
195.6
|
|
|
$
|
311.4
|
|
Investing activities
|
(480.3
|
)
|
|
318.4
|
|
|
(155.6
|
)
|
|
(77.2
|
)
|
|
215.4
|
|
|||||
Financing activities
|
(1,095.0
|
)
|
|
(130.2
|
)
|
|
(1,162.3
|
)
|
|
(53.9
|
)
|
|
(369.5
|
)
|
|||||
Effect of currency exchange rate changes on cash
|
(1.8
|
)
|
|
2.5
|
|
|
0.3
|
|
|
(3.0
|
)
|
|
(1.5
|
)
|
|||||
Net (decrease) increase in cash, cash equivalents and restricted cash
|
$
|
(911.6
|
)
|
|
$
|
918.0
|
|
|
$
|
(133.0
|
)
|
|
$
|
61.5
|
|
|
$
|
155.8
|
|
|
December 28, 2018
|
||
Variable-rate instruments:
|
|
||
Term loan due September 2024
|
$
|
1,613.8
|
|
Term loan due February 2025
|
597.0
|
|
|
Receivable Securitization program
|
250.0
|
|
|
Revolving credit facility
|
220.0
|
|
|
Fixed-rate instruments
|
3,475.9
|
|
|
Debt principal
|
$
|
6,156.7
|
|
|
Payments Due By Period
|
||||||||||||||||||
|
Total
|
|
Less than 1 year
|
|
1 - 3 years
|
|
3 - 5 years
|
|
More than 5 years
|
||||||||||
Long-term debt obligations
|
$
|
6,156.7
|
|
|
$
|
22.7
|
|
|
$
|
1,000.9
|
|
|
$
|
2,346.8
|
|
|
$
|
2,786.3
|
|
Interest on long-term debt obligations (1)
|
1,532.5
|
|
|
333.5
|
|
|
606.6
|
|
|
442.7
|
|
|
149.7
|
|
|||||
Operating lease obligations
|
111.6
|
|
|
22.3
|
|
|
29.2
|
|
|
20.9
|
|
|
39.2
|
|
|||||
Purchase obligations (2)
|
164.7
|
|
|
110.3
|
|
|
45.7
|
|
|
3.8
|
|
|
4.9
|
|
|||||
Total contractual obligations
|
$
|
7,965.5
|
|
|
$
|
488.8
|
|
|
$
|
1,682.4
|
|
|
$
|
2,814.2
|
|
|
$
|
2,980.1
|
|
(1)
|
Interest on long-term debt obligations are projected for future periods using interest rates in effect as of December 28, 2018. Certain of these projected interest payments may differ in the future based on changes in market interest rates.
|
(2)
|
Purchase obligations consist of commitments for purchases of goods and services made in the normal course of business to meet operational and capital requirements.
|
|
Rebates and Chargebacks
|
|
Product Returns
|
|
Other Sales Deductions
|
|
Total
|
||||||||
Balance at September 25, 2015
|
$
|
308.0
|
|
|
$
|
72.6
|
|
|
$
|
15.8
|
|
|
$
|
396.4
|
|
Provisions
|
1,937.9
|
|
|
14.3
|
|
|
78.6
|
|
|
2,030.8
|
|
||||
Payments or credits
|
(1,920.1
|
)
|
|
(47.9
|
)
|
|
(81.2
|
)
|
|
(2,049.2
|
)
|
||||
Balance at September 30, 2016
|
325.8
|
|
|
39.0
|
|
|
13.2
|
|
|
378.0
|
|
||||
Provisions
|
491.3
|
|
|
5.6
|
|
|
18.4
|
|
|
515.3
|
|
||||
Payments or credits
|
(468.0
|
)
|
|
(13.2
|
)
|
|
(20.8
|
)
|
|
(502.0
|
)
|
||||
Balance at December 30, 2016
|
349.1
|
|
|
31.4
|
|
|
10.8
|
|
|
391.3
|
|
||||
Provisions
|
1,897.2
|
|
|
38.7
|
|
|
72.6
|
|
|
2,008.5
|
|
||||
Payments or credits
|
(1,918.9
|
)
|
|
(35.6
|
)
|
|
(68.7
|
)
|
|
(2,023.2
|
)
|
||||
Balance at December 29, 2017
|
327.4
|
|
|
34.5
|
|
|
14.7
|
|
|
376.6
|
|
||||
Provisions
|
2,281.3
|
|
|
39.3
|
|
|
66.9
|
|
|
2,387.5
|
|
||||
Payments or credits
|
(2,254.4
|
)
|
|
(39.8
|
)
|
|
(64.5
|
)
|
|
(2,358.7
|
)
|
||||
Balance at December 28, 2018
|
$
|
354.3
|
|
|
$
|
34.0
|
|
|
$
|
17.1
|
|
|
$
|
405.4
|
|
•
|
For those contracts whereby revenue is recognized over time based upon consumption of the product, we either have:
|
1.
|
the right to invoice the customer in an amount that directly corresponds with the value to the customer of our performance to date, for which the practical expedient to recognize in proportion to the amount it has the right to invoice has been applied, or
|
2.
|
the remaining goods and services to which the customer is entitled is diminished upon consumption.
|
Item 7A.
|
Quantitative and Qualitative Disclosures About Market Risk.
|
Item 8.
|
Financial Statements and Supplementary Data.
|
Consolidated Financial Statements
|
|
|
|
Report of Independent Registered Public Accounting Firm.
|
|
Consolidated Statements of Income for the fiscal years ended December 28, 2018, December 29, 2017 and September 30, 2016 and the three months ended December 30, 2016.
|
|
Consolidated Statements of Comprehensive Income for the fiscal years ended December 28, 2018, December 29, 2017 and September 30, 2016 and the three months ended December 30, 2016.
|
|
Consolidated Balance Sheets as of December 28, 2018 and December 29, 2017.
|
|
Consolidated Statements of Cash Flows for the fiscal years ended December 28, 2018, December 29, 2017 and September 30, 2016 and the three months ended December 30, 2016.
|
|
Consolidated Statement of Changes in Shareholders' Equity for the period from September 25, 2015 to December 28, 2018.
|
|
Notes to Consolidated Financial Statements.
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016 |
||||||||
Net sales
|
$
|
3,215.6
|
|
|
$
|
3,221.6
|
|
|
$
|
3,380.8
|
|
|
$
|
829.9
|
|
Cost of sales
|
1,744.4
|
|
|
1,564.1
|
|
|
1,523.2
|
|
|
383.2
|
|
||||
Gross profit
|
1,471.2
|
|
|
1,657.5
|
|
|
1,857.6
|
|
|
446.7
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative expenses
|
834.1
|
|
|
849.7
|
|
|
913.7
|
|
|
321.1
|
|
||||
Research and development expenses
|
361.1
|
|
|
276.9
|
|
|
261.2
|
|
|
66.1
|
|
||||
Restructuring charges, net
|
103.0
|
|
|
31.2
|
|
|
32.7
|
|
|
3.8
|
|
||||
Non-restructuring impairment charges
|
3,893.1
|
|
|
63.7
|
|
|
16.9
|
|
|
214.3
|
|
||||
Losses (gains) on divestiture
|
0.8
|
|
|
(56.9
|
)
|
|
—
|
|
|
—
|
|
||||
Operating (loss) income
|
(3,720.9
|
)
|
|
492.9
|
|
|
633.1
|
|
|
(158.6
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Interest expense
|
(370.2
|
)
|
|
(369.1
|
)
|
|
(384.6
|
)
|
|
(91.3
|
)
|
||||
Interest income
|
8.2
|
|
|
4.6
|
|
|
1.3
|
|
|
0.5
|
|
||||
Other income (expense), net
|
30.9
|
|
|
(66.8
|
)
|
|
(16.4
|
)
|
|
(49.1
|
)
|
||||
(Loss) income from continuing operations before income taxes
|
(4,052.0
|
)
|
|
61.6
|
|
|
233.4
|
|
|
(298.5
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Benefit from income taxes
|
(430.1
|
)
|
|
(1,709.6
|
)
|
|
(255.6
|
)
|
|
(121.7
|
)
|
||||
(Loss) income from continuing operations
|
(3,621.9
|
)
|
|
1,771.2
|
|
|
489.0
|
|
|
(176.8
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Income from discontinued operations, net of tax expense of $1.4, $5.4, $43.5,
and $15.3
|
14.9
|
|
|
363.2
|
|
|
154.7
|
|
|
23.6
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Net (loss) income
|
$
|
(3,607.0
|
)
|
|
$
|
2,134.4
|
|
|
$
|
643.7
|
|
|
$
|
(153.2
|
)
|
|
|
|
|
|
|
|
|
||||||||
Basic earnings per share (Note 10):
|
|
|
|
|
|
|
|
||||||||
(Loss) income from continuing operations
|
$
|
(43.12
|
)
|
|
$
|
18.13
|
|
|
$
|
4.42
|
|
|
$
|
(1.67
|
)
|
Income from discontinued operations, net of income taxes
|
0.18
|
|
|
3.72
|
|
|
1.40
|
|
|
0.22
|
|
||||
Net (loss) income
|
$
|
(42.94
|
)
|
|
$
|
21.85
|
|
|
$
|
5.82
|
|
|
$
|
(1.45
|
)
|
|
|
|
|
|
|
|
|
||||||||
Basic weighted-average shares outstanding
|
84.0
|
|
|
97.7
|
|
|
110.6
|
|
|
105.7
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Diluted earnings per share (Note 10):
|
|
|
|
|
|
|
|
||||||||
(Loss) income from continuing operations
|
$
|
(43.12
|
)
|
|
$
|
18.09
|
|
|
$
|
4.39
|
|
|
$
|
(1.67
|
)
|
Income from discontinued operations, net of income taxes
|
0.18
|
|
|
3.71
|
|
|
1.39
|
|
|
0.22
|
|
||||
Net (loss) income
|
$
|
(42.94
|
)
|
|
$
|
21.80
|
|
|
$
|
5.77
|
|
|
$
|
(1.45
|
)
|
|
|
|
|
|
|
|
|
||||||||
Diluted weighted-average shares outstanding
|
84.0
|
|
|
97.9
|
|
|
111.5
|
|
|
105.7
|
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016 |
||||||||
Net (loss) income
|
$
|
(3,607.0
|
)
|
|
$
|
2,134.4
|
|
|
$
|
643.7
|
|
|
$
|
(153.2
|
)
|
Other comprehensive (loss) income, net of tax
|
|
|
|
|
|
|
|
||||||||
Currency translation adjustments
|
(12.2
|
)
|
|
11.3
|
|
|
(58.6
|
)
|
|
(21.1
|
)
|
||||
Unrecognized gain on derivatives, net of tax expense of $0.2, $0.3, $0.2, and $-
|
0.7
|
|
|
1.0
|
|
|
0.5
|
|
|
0.2
|
|
||||
Unrecognized gain (loss) on benefit plans, net of tax expense (benefit) of $0.5, $30.8, ($15.0), and ($19.3)
|
1.6
|
|
|
45.8
|
|
|
(28.4
|
)
|
|
34.0
|
|
||||
Unrecognized gain on investments
|
—
|
|
|
1.5
|
|
|
—
|
|
|
—
|
|
||||
Total other comprehensive (loss) income, net of tax
|
(9.9
|
)
|
|
59.6
|
|
|
(86.5
|
)
|
|
13.1
|
|
||||
Comprehensive (loss) income
|
$
|
(3,616.9
|
)
|
|
$
|
2,194.0
|
|
|
$
|
557.2
|
|
|
$
|
(140.1
|
)
|
|
December 28,
2018 |
|
December 29,
2017 |
||||
Assets
|
|
|
|
||||
Current Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
348.9
|
|
|
$
|
1,260.9
|
|
Accounts receivable, less allowance for doubtful accounts of $5.0 and $3.9
|
623.3
|
|
|
445.8
|
|
||
Inventories
|
322.3
|
|
|
340.4
|
|
||
Prepaid expenses and other current assets
|
132.7
|
|
|
84.1
|
|
||
Notes receivable
|
—
|
|
|
154.0
|
|
||
Total current assets
|
1,427.2
|
|
|
2,285.2
|
|
||
Property, plant and equipment, net
|
982.0
|
|
|
966.8
|
|
||
Goodwill
|
—
|
|
|
3,482.7
|
|
||
Intangible assets, net
|
8,282.8
|
|
|
8,375.0
|
|
||
Other assets
|
185.3
|
|
|
171.2
|
|
||
Total Assets
|
$
|
10,877.3
|
|
|
$
|
15,280.9
|
|
Liabilities and Shareholders' Equity
|
|
|
|
||||
Current Liabilities:
|
|
|
|
||||
Current maturities of long-term debt
|
$
|
22.4
|
|
|
$
|
313.7
|
|
Accounts payable
|
147.5
|
|
|
113.3
|
|
||
Accrued payroll and payroll-related costs
|
124.0
|
|
|
98.5
|
|
||
Accrued interest
|
77.6
|
|
|
57.0
|
|
||
Income taxes payable
|
25.0
|
|
|
15.8
|
|
||
Accrued and other current liabilities
|
547.2
|
|
|
452.1
|
|
||
Total current liabilities
|
943.7
|
|
|
1,050.4
|
|
||
Long-term debt
|
6,069.2
|
|
|
6,420.9
|
|
||
Pension and postretirement benefits
|
60.5
|
|
|
67.1
|
|
||
Environmental liabilities
|
59.7
|
|
|
73.2
|
|
||
Deferred income taxes
|
324.3
|
|
|
689.0
|
|
||
Other income tax liabilities
|
228.0
|
|
|
94.1
|
|
||
Other liabilities
|
304.6
|
|
|
364.2
|
|
||
Total Liabilities
|
7,990.0
|
|
|
8,758.9
|
|
||
Shareholders' Equity:
|
|
|
|
||||
Preferred shares, $0.20 par value, 500,000,000 authorized; none issued or outstanding
|
—
|
|
|
—
|
|
||
Ordinary A shares, €1.00 par value, 40,000 authorized; none issued or outstanding
|
—
|
|
|
—
|
|
||
Ordinary shares, $0.20 par value, 500,000,000 authorized; 92,705,747 and 92,196,662 issued; 83,323,877 and 86,336,232 outstanding
|
18.5
|
|
|
18.4
|
|
||
Ordinary shares held in treasury at cost, 9,381,870 and 5,860,430
|
(1,617.4
|
)
|
|
(1,564.7
|
)
|
||
Additional paid-in capital
|
5,528.2
|
|
|
5,492.6
|
|
||
Retained (deficit) earnings
|
(1,017.7
|
)
|
|
2,588.6
|
|
||
Accumulated other comprehensive loss
|
(24.3
|
)
|
|
(12.9
|
)
|
||
Total Shareholders' Equity
|
2,887.3
|
|
|
6,522.0
|
|
||
Total Liabilities and Shareholders' Equity
|
$
|
10,877.3
|
|
|
$
|
15,280.9
|
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Cash Flows From Operating Activities:
|
|
|
|
|
|
|
|
||||||||
Net (loss) income
|
$
|
(3,607.0
|
)
|
|
$
|
2,134.4
|
|
|
$
|
643.7
|
|
|
$
|
(153.2
|
)
|
Adjustments to reconcile net cash provided by operating activities:
|
|
|
|
|
|
|
|
||||||||
Depreciation and amortization
|
852.1
|
|
|
808.3
|
|
|
834.5
|
|
|
203.2
|
|
||||
Share-based compensation
|
34.6
|
|
|
59.2
|
|
|
42.9
|
|
|
11.0
|
|
||||
Deferred income taxes
|
(541.5
|
)
|
|
(1,744.1
|
)
|
|
(432.9
|
)
|
|
(204.3
|
)
|
||||
Non-cash impairment charges
|
3,893.1
|
|
|
63.7
|
|
|
16.9
|
|
|
214.3
|
|
||||
Inventory provisions
|
37.9
|
|
|
34.1
|
|
|
29.2
|
|
|
8.5
|
|
||||
Loss (gain) on divestiture
|
0.8
|
|
|
(418.1
|
)
|
|
(95.3
|
)
|
|
—
|
|
||||
Other non-cash items
|
(50.9
|
)
|
|
(21.4
|
)
|
|
29.6
|
|
|
(9.2
|
)
|
||||
Changes in assets and liabilities, net of the effects of acquisitions:
|
|
|
|
|
|
|
|
||||||||
Accounts receivable, net
|
(145.8
|
)
|
|
(16.2
|
)
|
|
31.2
|
|
|
36.5
|
|
||||
Inventories
|
63.1
|
|
|
(23.6
|
)
|
|
(17.3
|
)
|
|
(26.3
|
)
|
||||
Accounts payable
|
24.6
|
|
|
(25.8
|
)
|
|
(9.7
|
)
|
|
5.4
|
|
||||
Income taxes
|
99.0
|
|
|
(34.2
|
)
|
|
93.9
|
|
|
0.6
|
|
||||
Other
|
5.5
|
|
|
(89.0
|
)
|
|
17.9
|
|
|
109.1
|
|
||||
Net cash from operating activities
|
665.5
|
|
|
727.3
|
|
|
1,184.6
|
|
|
195.6
|
|
||||
Cash Flows From Investing Activities:
|
|
|
|
|
|
|
|
||||||||
Capital expenditures
|
(127.0
|
)
|
|
(186.1
|
)
|
|
(182.9
|
)
|
|
(65.2
|
)
|
||||
Acquisitions, net of cash acquired
|
(699.9
|
)
|
|
(76.3
|
)
|
|
(245.4
|
)
|
|
(1.8
|
)
|
||||
Proceeds from divestiture, net of cash
|
313.0
|
|
|
576.9
|
|
|
266.7
|
|
|
—
|
|
||||
Other
|
33.6
|
|
|
3.9
|
|
|
6.0
|
|
|
(10.2
|
)
|
||||
Net cash from investing activities
|
(480.3
|
)
|
|
318.4
|
|
|
(155.6
|
)
|
|
(77.2
|
)
|
||||
Cash Flows From Financing Activities:
|
|
|
|
|
|
|
|
||||||||
Issuance of external debt
|
690.3
|
|
|
1,465.0
|
|
|
98.3
|
|
|
190.0
|
|
||||
Repayment of external debt and capital lease obligation
|
(1,693.6
|
)
|
|
(917.2
|
)
|
|
(568.6
|
)
|
|
(86.7
|
)
|
||||
Debt financing costs
|
(12.1
|
)
|
|
(12.7
|
)
|
|
(0.1
|
)
|
|
—
|
|
||||
Proceeds from exercise of share options
|
1.0
|
|
|
4.1
|
|
|
14.0
|
|
|
0.4
|
|
||||
Repurchase of shares
|
(57.5
|
)
|
|
(651.7
|
)
|
|
(652.9
|
)
|
|
(158.8
|
)
|
||||
Other
|
(23.1
|
)
|
|
(17.7
|
)
|
|
(53.0
|
)
|
|
1.2
|
|
||||
Net cash from financing activities
|
(1,095.0
|
)
|
|
(130.2
|
)
|
|
(1,162.3
|
)
|
|
(53.9
|
)
|
||||
Effect of currency rate changes on cash
|
(1.8
|
)
|
|
2.5
|
|
|
0.3
|
|
|
(3.0
|
)
|
||||
Net change in cash, cash equivalents and restricted cash
|
(911.6
|
)
|
|
918.0
|
|
|
(133.0
|
)
|
|
61.5
|
|
||||
Cash, cash equivalents and restricted cash at beginning of period
|
1,279.1
|
|
|
361.1
|
|
|
432.6
|
|
|
299.6
|
|
||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
367.5
|
|
|
$
|
1,279.1
|
|
|
$
|
299.6
|
|
|
$
|
361.1
|
|
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents at end of period
|
$
|
348.9
|
|
|
$
|
1,260.9
|
|
|
$
|
280.5
|
|
|
$
|
342.0
|
|
Restricted cash included in prepaid expenses and other assets at end of period
|
—
|
|
|
—
|
|
|
0.1
|
|
|
0.1
|
|
||||
Restricted cash included in other long-term assets at end of period
|
18.6
|
|
|
18.2
|
|
|
19.0
|
|
|
19.0
|
|
||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
367.5
|
|
|
$
|
1,279.1
|
|
|
$
|
299.6
|
|
|
$
|
361.1
|
|
|
|
|
|
|
|
|
|
||||||||
Supplemental Disclosures of Cash Flow Information:
|
|
|
|
|
|
|
|
||||||||
Cash paid for interest
|
$
|
309.7
|
|
|
$
|
339.1
|
|
|
$
|
332.4
|
|
|
$
|
95.4
|
|
Cash paid for income taxes, net
|
12.4
|
|
|
73.4
|
|
|
165.4
|
|
|
95.6
|
|
|
Ordinary Shares
|
|
Treasury Shares
|
|
Additional Paid-In Capital
|
|
Retained Earnings
|
|
Accumulated
Other
Comprehensive
Income
|
|
Total
Shareholders'
Equity
|
||||||||||||||||||
|
Number
|
|
Par
Value
|
|
Number
|
|
Amount
|
|
|||||||||||||||||||||
Balance at September 25, 2015
|
117.5
|
|
|
$
|
23.5
|
|
|
1.2
|
|
|
$
|
(109.7
|
)
|
|
$
|
5,357.6
|
|
|
$
|
38.9
|
|
|
$
|
0.9
|
|
|
$
|
5,311.2
|
|
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
643.7
|
|
|
—
|
|
|
643.7
|
|
||||||
Currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(58.6
|
)
|
|
(58.6
|
)
|
||||||
Change in derivatives, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
0.5
|
|
|
0.5
|
|
||||||
Minimum pension liability, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(28.4
|
)
|
|
(28.4
|
)
|
||||||
Share options exercised
|
0.4
|
|
|
0.1
|
|
|
—
|
|
|
—
|
|
|
13.9
|
|
|
—
|
|
|
—
|
|
|
14.0
|
|
||||||
Vesting of restricted shares
|
0.2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Excess tax benefit from share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1.7
|
)
|
|
—
|
|
|
—
|
|
|
(1.7
|
)
|
||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
42.9
|
|
|
—
|
|
|
—
|
|
|
42.9
|
|
||||||
Repurchase of shares
|
—
|
|
|
—
|
|
|
9.8
|
|
|
(652.9
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(652.9
|
)
|
||||||
Balance at September 30, 2016
|
118.1
|
|
|
$
|
23.6
|
|
|
11.0
|
|
|
$
|
(762.6
|
)
|
|
$
|
5,412.7
|
|
|
$
|
682.6
|
|
|
$
|
(85.6
|
)
|
|
$
|
5,270.7
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(153.2
|
)
|
|
—
|
|
|
(153.2
|
)
|
||||||
Currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(21.1
|
)
|
|
(21.1
|
)
|
||||||
Change in derivatives, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
0.2
|
|
|
0.2
|
|
||||||
Minimum pension liability, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
34.0
|
|
|
34.0
|
|
||||||
Share options exercised
|
0.1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
0.4
|
|
|
—
|
|
|
—
|
|
|
0.4
|
|
||||||
Excess tax benefit from share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(0.1
|
)
|
|
—
|
|
|
—
|
|
|
(0.1
|
)
|
||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11.0
|
|
|
—
|
|
|
—
|
|
|
11.0
|
|
||||||
Reissuance of Treasury shares
|
—
|
|
|
—
|
|
|
—
|
|
|
1.6
|
|
|
—
|
|
|
(0.4
|
)
|
|
—
|
|
|
1.2
|
|
||||||
Repurchase of shares
|
—
|
|
|
—
|
|
|
2.5
|
|
|
(158.8
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(158.8
|
)
|
||||||
Balance at December 30, 2016
|
118.2
|
|
|
$
|
23.6
|
|
|
13.5
|
|
|
$
|
(919.8
|
)
|
|
$
|
5,424.0
|
|
|
$
|
529.0
|
|
|
$
|
(72.5
|
)
|
|
$
|
4,984.3
|
|
Impact of accounting standard adoptions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(72.1
|
)
|
|
—
|
|
|
(72.1
|
)
|
||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,134.4
|
|
|
—
|
|
|
2,134.4
|
|
||||||
Currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11.3
|
|
|
11.3
|
|
||||||
Change in derivatives, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1.0
|
|
|
1.0
|
|
||||||
Minimum pension liability, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
45.8
|
|
|
45.8
|
|
||||||
Unrecognized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1.5
|
|
|
1.5
|
|
||||||
Share options exercised
|
0.1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4.1
|
|
|
—
|
|
|
—
|
|
|
4.1
|
|
||||||
Vesting of restricted shares
|
0.4
|
|
|
0.1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
0.1
|
|
||||||
Shares canceled
|
(26.5
|
)
|
|
(5.3
|
)
|
|
(26.5
|
)
|
|
—
|
|
|
5.3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
59.2
|
|
|
—
|
|
|
—
|
|
|
59.2
|
|
||||||
Reissuance of Treasury shares
|
—
|
|
|
—
|
|
|
—
|
|
|
6.8
|
|
|
—
|
|
|
(2.7
|
)
|
|
—
|
|
|
4.1
|
|
||||||
Repurchase of shares
|
—
|
|
|
—
|
|
|
18.9
|
|
|
(651.7
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(651.7
|
)
|
||||||
Balance at December 29, 2017
|
92.2
|
|
|
$
|
18.4
|
|
|
5.9
|
|
|
$
|
(1,564.7
|
)
|
|
$
|
5,492.6
|
|
|
$
|
2,588.6
|
|
|
$
|
(12.9
|
)
|
|
$
|
6,522.0
|
|
Impact of accounting standard adoptions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2.6
|
|
|
(1.5
|
)
|
|
1.1
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,607.0
|
)
|
|
—
|
|
|
(3,607.0
|
)
|
||||||
Currency translation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(12.2
|
)
|
|
(12.2
|
)
|
||||||
Change in derivatives, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
0.7
|
|
|
0.7
|
|
||||||
Minimum pension liability, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1.6
|
|
|
1.6
|
|
||||||
Share options exercised
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1.0
|
|
|
—
|
|
|
—
|
|
|
1.0
|
|
||||||
Vesting of restricted shares
|
0.5
|
|
|
0.1
|
|
|
0.1
|
|
|
(2.3
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2.2
|
)
|
||||||
Share-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
34.6
|
|
|
—
|
|
|
—
|
|
|
34.6
|
|
||||||
Reissuance of Treasury shares
|
—
|
|
|
—
|
|
|
(0.2
|
)
|
|
4.8
|
|
|
—
|
|
|
(1.9
|
)
|
|
—
|
|
|
2.9
|
|
||||||
Repurchase of shares
|
—
|
|
|
—
|
|
|
3.6
|
|
|
(55.2
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(55.2
|
)
|
||||||
Balance at December 28, 2018
|
92.7
|
|
|
$
|
18.5
|
|
|
9.4
|
|
|
$
|
(1,617.4
|
)
|
|
$
|
5,528.2
|
|
|
$
|
(1,017.7
|
)
|
|
$
|
(24.3
|
)
|
|
$
|
2,887.3
|
|
1.
|
Background and Basis of Presentation
|
•
|
Specialty Brands includes innovative specialty pharmaceutical brands; and
|
•
|
Specialty Generics and Amitiza includes niche specialty generic drug products, active pharmaceutical ingredients ("API(s)") and Amitiza® (lubiprostone) ("Amitiza").
|
2.
|
Transition Period
|
Consolidated Statements of Income
|
Three Months Ended
|
||||||
|
December 30, 2016 |
|
(unaudited)
December 25, 2015 (1) |
||||
Net sales
|
$
|
829.9
|
|
|
$
|
811.2
|
|
Cost of sales
|
383.2
|
|
|
360.0
|
|
||
Gross profit
|
446.7
|
|
|
451.2
|
|
||
|
|
|
|
||||
Selling, general and administrative expenses
|
321.1
|
|
|
221.8
|
|
||
Research and development expenses
|
66.1
|
|
|
61.3
|
|
||
Restructuring charges, net
|
3.8
|
|
|
4.1
|
|
||
Non-restructuring impairment charges
|
214.3
|
|
|
—
|
|
||
Operating (loss) income
|
(158.6
|
)
|
|
164.0
|
|
||
|
|
|
|
||||
Interest expense
|
(91.3
|
)
|
|
(97.8
|
)
|
||
Interest income
|
0.5
|
|
|
0.2
|
|
||
Other (expense) income, net
|
(49.1
|
)
|
|
0.1
|
|
||
(Loss) income from continuing operations before income taxes
|
(298.5
|
)
|
|
66.5
|
|
||
|
|
|
|
||||
Benefit from income taxes
|
(121.7
|
)
|
|
(37.3
|
)
|
||
(Loss) income from continuing operations
|
(176.8
|
)
|
|
103.8
|
|
||
|
|
|
|
||||
Income from discontinued operations
|
23.6
|
|
|
107.3
|
|
||
|
|
|
|
||||
Net (loss) income
|
$
|
(153.2
|
)
|
|
$
|
211.1
|
|
|
|
|
|
||||
Basic earnings per share (Note 10):
|
|
|
|
||||
(Loss) income from continuing operations
|
$
|
(1.67
|
)
|
|
$
|
0.90
|
|
Income from discontinued operations, net of income taxes
|
0.22
|
|
|
0.93
|
|
||
Net (loss) income
|
$
|
(1.45
|
)
|
|
$
|
1.83
|
|
|
|
|
|
||||
Basic weighted-average shares outstanding
|
105.7
|
|
|
115.4
|
|
||
|
|
|
|
||||
Diluted earnings per share (Note 10):
|
|
|
|
||||
(Loss) income from continuing operations
|
$
|
(1.67
|
)
|
|
$
|
0.89
|
|
Income from discontinued operations, net of income taxes
|
0.22
|
|
|
0.92
|
|
||
Net (loss) income
|
$
|
(1.45
|
)
|
|
$
|
1.82
|
|
|
|
|
|
||||
Diluted weighted-average shares outstanding
|
105.7
|
|
|
116.3
|
|
(1)
|
Financial data for this period has been adjusted to reflect the change in accounting for pension and postretirement costs with the adoption of Accounting Standards Update ("ASU") 2017-07. See Note 4 for further information on this ASU.
|
Consolidated Statements of Cash Flows
|
Three Months Ended
|
||||||
|
December 30, 2016
|
|
(unaudited) December 25, 2015
|
||||
Cash Flows From Operating Activities:
|
|
|
|
||||
Net (loss) income
|
$
|
(153.2
|
)
|
|
$
|
211.1
|
|
Adjustments to reconcile net cash provided by operating activities:
|
|
|
|
||||
Depreciation and amortization
|
203.2
|
|
|
206.0
|
|
||
Share-based compensation
|
11.0
|
|
|
8.5
|
|
||
Deferred income taxes
|
(204.3
|
)
|
|
(108.9
|
)
|
||
Non-cash impairment charges
|
214.3
|
|
|
—
|
|
||
Inventory provisions
|
8.5
|
|
|
1.2
|
|
||
Gain on disposal of discontinued operations
|
—
|
|
|
(97.0
|
)
|
||
Other non-cash items
|
(9.2
|
)
|
|
2.9
|
|
||
Changes in assets and liabilities, net of the effects of acquisitions:
|
|
|
|
||||
Accounts receivable, net
|
36.5
|
|
|
68.4
|
|
||
Inventories
|
(26.3
|
)
|
|
(14.5
|
)
|
||
Accounts payable
|
5.4
|
|
|
(13.0
|
)
|
||
Income taxes
|
0.6
|
|
|
82.3
|
|
||
Other
|
109.1
|
|
|
(35.6
|
)
|
||
Net cash from operating activities
|
195.6
|
|
|
311.4
|
|
||
Cash Flows From Investing Activities:
|
|
|
|
||||
Capital expenditures
|
(65.2
|
)
|
|
(49.0
|
)
|
||
Acquisitions and intangibles, net of cash acquired
|
(1.8
|
)
|
|
—
|
|
||
Proceeds from disposal of discontinued operations, net of cash
|
—
|
|
|
263.7
|
|
||
Other
|
(10.2
|
)
|
|
0.7
|
|
||
Net cash from investing activities
|
(77.2
|
)
|
|
215.4
|
|
||
Cash Flows From Financing Activities:
|
|
|
|
||||
Issuance of external debt
|
190.0
|
|
|
62.0
|
|
||
Repayment of external debt and capital leases
|
(86.7
|
)
|
|
(129.6
|
)
|
||
Debt financing costs
|
—
|
|
|
(0.1
|
)
|
||
Proceeds from exercise of share options
|
0.4
|
|
|
3.6
|
|
||
Repurchase of shares
|
(158.8
|
)
|
|
(275.4
|
)
|
||
Other
|
1.2
|
|
|
(30.0
|
)
|
||
Net cash from financing activities
|
(53.9
|
)
|
|
(369.5
|
)
|
||
Effect of currency rate changes on cash
|
(3.0
|
)
|
|
(1.5
|
)
|
||
Net change in cash, cash equivalents and restricted cash
|
61.5
|
|
|
155.8
|
|
||
Cash, cash equivalents and restricted cash at beginning of period
|
299.6
|
|
|
432.6
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
361.1
|
|
|
$
|
588.4
|
|
|
|
|
|
||||
Cash and cash equivalents at end of period
|
$
|
342.0
|
|
|
$
|
521.9
|
|
Restricted cash included in prepaid expenses and other assets at end of period
|
0.1
|
|
|
47.5
|
|
||
Restricted cash included in other long-term assets at end of period
|
19.0
|
|
|
19.0
|
|
||
Cash, cash equivalents and restricted cash at end of period
|
$
|
361.1
|
|
|
$
|
588.4
|
|
3.
|
Summary of Significant Accounting Policies
|
•
|
For those contracts whereby revenue is recognized over time based upon consumption of the product, the Company either has:
|
1.
|
the right to invoice the customer in an amount that directly corresponds with the value to the customer of the Company's performance to date, for which the practical expedient to recognize in proportion to the amount it has the right to invoice has been applied, or
|
2.
|
the remaining goods and services to which the customer is entitled is diminished upon consumption.
|
•
|
For those contracts whereby revenue is recognized over time based upon the passage of time, the benefit that the customer receives from unlimited access to the Company's product does not vary, regardless of consumption. As a result, the Company's obligation diminishes with the passage of time; therefore, it was determined that ratable recognition of the transaction price over the contract period is the measure that best aligns with how the obligation is satisfied.
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Shipping and handling costs
|
$
|
12.8
|
|
|
$
|
13.9
|
|
|
$
|
12.4
|
|
|
$
|
3.4
|
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016 |
||||||||
Foreign currency (losses), gains
|
$
|
(3.1
|
)
|
|
$
|
2.5
|
|
|
$
|
(3.6
|
)
|
|
$
|
9.0
|
|
Derivative hedge gains (losses)
|
2.7
|
|
|
(4.1
|
)
|
|
0.2
|
|
|
(8.9
|
)
|
Buildings
|
10
|
to
|
45 years
|
Leasehold improvements
|
1
|
to
|
20 years
|
Capitalized software
|
1
|
to
|
10 years
|
Machinery and equipment
|
1
|
to
|
20 years
|
Completed technology
|
5
|
to
|
25 years
|
License agreements
|
7
|
to
|
30 years
|
Trademarks
|
13
|
to
|
30 years
|
Customer relationships
|
|
|
12 years
|
4.
|
Recently Issued Accounting Standards
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||
|
December 29,
2017 |
|
September 30,
2016 |
|
December 30,
2016 |
||||||
Cost of sales
|
$
|
1.2
|
|
|
$
|
2.6
|
|
|
$
|
0.9
|
|
Selling, general and administrative expenses
|
71.2
|
|
|
11.6
|
|
|
47.2
|
|
|||
Research and development expenses
|
0.4
|
|
|
1.0
|
|
|
0.1
|
|
|||
Restructuring charges, net
|
—
|
|
|
0.6
|
|
|
—
|
|
|||
Other income (expense), net
|
$
|
72.8
|
|
|
$
|
15.8
|
|
|
$
|
48.2
|
|
5.
|
Revenue from Contracts with Customers
|
|
Rebates and Chargebacks
|
|
Product Returns
|
|
Other Sales Deductions
|
|
Total
|
||||||||
Balance as of December 29, 2017
|
$
|
327.4
|
|
|
$
|
34.5
|
|
|
$
|
14.7
|
|
|
$
|
376.6
|
|
Provisions
|
2,281.3
|
|
|
39.3
|
|
|
66.9
|
|
|
2,387.5
|
|
||||
Payments or credits
|
(2,254.4
|
)
|
|
(39.8
|
)
|
|
(64.5
|
)
|
|
(2,358.7
|
)
|
||||
Balance as of December 28, 2018
|
$
|
354.3
|
|
|
$
|
34.0
|
|
|
$
|
17.1
|
|
|
$
|
405.4
|
|
Fiscal 2019
|
$
|
145.0
|
|
Fiscal 2020
|
127.3
|
|
|
Fiscal 2021
|
32.6
|
|
|
Thereafter
|
3.2
|
|
|
December 28,
2018 |
|
December 29,
2017 |
||||
Accrued and other current liabilities
|
$
|
20.4
|
|
|
$
|
14.0
|
|
Other liabilities
|
15.1
|
|
|
6.6
|
|
||
Contract liabilities
|
$
|
35.5
|
|
|
$
|
20.6
|
|
6.
|
Discontinued Operations and Divestitures
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||
Depreciation
|
$
|
—
|
|
|
$
|
20.9
|
|
|
$
|
—
|
|
Capital expenditures
|
0.3
|
|
|
9.7
|
|
|
2.0
|
|
|
Fiscal Year Ended
|
||
Major line items constituting (loss) income from discontinued operations
|
September 30, 2016
|
||
Net sales
|
$
|
61.0
|
|
Cost of sales
|
46.9
|
|
|
Selling, general and administrative
|
20.3
|
|
|
Other
|
1.2
|
|
|
Loss from discontinued operations
|
(7.4
|
)
|
|
Gain on disposal of discontinued operations
|
95.3
|
|
|
Income from discontinued operations, before income taxes
|
87.9
|
|
|
Income tax benefit
|
(2.5
|
)
|
|
Income from discontinued operations net of tax
|
$
|
90.4
|
|
7.
|
Acquisitions and License Agreements
|
|
Sucampo
|
|
Ocera (1)
|
|
InfaCare (2)
|
|
Stratatech
|
|
Hemostasis (3)
|
||||||||||
Acquisition Date
|
February 2018
|
|
December 2017
|
|
September 2017
|
|
August 2016
|
|
February 2016
|
||||||||||
Cash
|
$
|
149.6
|
|
|
$
|
1.0
|
|
|
$
|
1.3
|
|
|
$
|
0.2
|
|
|
$
|
3.3
|
|
Accounts receivable
|
35.7
|
|
|
—
|
|
|
—
|
|
|
1.3
|
|
|
—
|
|
|||||
Inventory
|
153.2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
94.6
|
|
|||||
Intangible assets
|
919.5
|
|
|
64.5
|
|
|
113.5
|
|
|
99.8
|
|
|
132.7
|
|
|||||
Goodwill (non-tax deductible) (4)
|
248.6
|
|
|
18.0
|
|
|
11.4
|
|
|
55.1
|
|
|
3.3
|
|
|||||
Other assets, current and non-current
|
25.8
|
|
|
0.4
|
|
|
0.1
|
|
|
1.9
|
|
|
7.9
|
|
|||||
Total assets acquired
|
1,532.4
|
|
|
83.9
|
|
|
126.3
|
|
|
158.3
|
|
|
241.8
|
|
|||||
Current liabilities
|
109.4
|
|
|
12.0
|
|
|
14.5
|
|
|
4.3
|
|
|
3.6
|
|
|||||
Other liabilities (non-current)
|
33.3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10.6
|
|
|||||
Deferred tax liabilities, net (non-current)
|
175.8
|
|
|
16.7
|
|
|
8.7
|
|
|
22.1
|
|
|
2.1
|
|
|||||
Contingent consideration (non-current)
|
—
|
|
|
12.8
|
|
|
35.0
|
|
|
54.9
|
|
|
52.0
|
|
|||||
Debt
|
366.3
|
|
|
—
|
|
|
30.0
|
|
|
1.0
|
|
|
—
|
|
|||||
Total liabilities assumed
|
684.8
|
|
|
41.5
|
|
|
88.2
|
|
|
82.3
|
|
|
68.3
|
|
|||||
Net assets acquired
|
$
|
847.6
|
|
|
$
|
42.4
|
|
|
$
|
38.1
|
|
|
$
|
76.0
|
|
|
$
|
173.5
|
|
(1)
|
Of the $42.4 million net assets acquired for Ocera, $40.5 million and $1.9 million was paid in fiscal 2017 and 2018, respectively.
|
(2)
|
During fiscal 2018, the Company reduced the contingent consideration liability related to this acquisition to zero through the recognition of a $35.0 million fair value adjustment. Refer to Note 21 for further information.
|
(3)
|
During fiscal 2017, the Company recorded a non-restructuring impairment charge relating to its Raplixa intangible asset and reduced the associated contingent consideration liability. During fiscal 2018, the Company sold its Recothrom and PreveLeak assets to Baxter. Refer to Notes 6, 13 and 21, respectively, for further information.
|
(4)
|
Refer to Note 13 for further information relating to the full goodwill impairment recorded in fiscal 2018.
|
|
Sucampo
|
|
Ocera (1)
|
|
InfaCare
|
|
Stratatech
|
|
Hemostasis
|
||||||||||
Total consideration, net of cash
|
$
|
698.0
|
|
|
$
|
63.4
|
|
|
$
|
71.8
|
|
|
$
|
130.7
|
|
|
$
|
222.2
|
|
Plus: cash assumed in acquisition
|
149.6
|
|
|
1.0
|
|
|
1.3
|
|
|
0.2
|
|
|
3.3
|
|
|||||
Total consideration
|
847.6
|
|
|
64.4
|
|
|
73.1
|
|
|
130.9
|
|
|
225.5
|
|
|||||
Less: non-cash contingent consideration
|
—
|
|
|
(22.0
|
)
|
|
(35.0
|
)
|
|
(54.9
|
)
|
|
(52.0
|
)
|
|||||
Net assets acquired
|
$
|
847.6
|
|
|
$
|
42.4
|
|
|
$
|
38.1
|
|
|
$
|
76.0
|
|
|
$
|
173.5
|
|
(1)
|
$1.9 million of the total consideration, net of cash was paid in fiscal 2018, subsequent to the Company's December 11, 2017 acquisition date.
|
Acquisition
|
|
Intangible Asset Acquired
|
|
Amount
|
|
Amortization Period
|
|
Discount Rate
|
|
Segment
|
|||
Sucampo
|
|
Completed technology - Amitiza
|
|
$
|
634.0
|
|
|
9 years
|
|
14.0
|
%
|
|
Specialty Generics and Amitiza
|
Sucampo
|
|
Completed technology - Other
|
|
11.0
|
|
|
8 years
|
|
14.0
|
%
|
|
Specialty Generics and Amitiza
|
|
Sucampo
|
|
In-process research and development - VTS-270
|
|
274.5
|
|
|
Non-Amortizable
|
|
15.0
|
%
|
|
Specialty Brands
|
|
Ocera
|
|
In-process research and development - MNK-6105/6106
|
|
64.5
|
|
|
Non-Amortizable
|
|
15.5
|
%
|
|
Specialty Brands
|
|
InfaCare
|
|
In-process research and development - stannsoporfin
|
|
113.5
|
|
|
Non-Amortizable
|
|
13.5
|
%
|
|
Specialty Brands
|
|
Stratatech
|
|
In-process research and development - StrataGraft
|
|
99.8
|
|
|
Non-Amortizable
|
|
16.5
|
%
|
|
Specialty Brands
|
|
Hemostasis
|
|
Completed technology - Raplixa (1)
|
|
73.0
|
|
|
15 years
|
|
17.0
|
%
|
|
Specialty Brands
|
|
Hemostasis
|
|
Completed technology - Recothrom (2)
|
|
42.7
|
|
|
13 years
|
|
16.0
|
%
|
|
Specialty Brands
|
|
Hemostasis
|
|
Completed technology - PreveLeak (2)
|
|
17.0
|
|
|
13 years
|
|
17.0
|
%
|
|
Specialty Brands
|
(1)
|
During fiscal 2017, the Company recorded a non-restructuring impairment charge relating to the Raplixa intangible asset. Refer to Note 13 for further information.
|
(2)
|
During fiscal 2018, the Company sold the Recothrom and PreveLeak assets to Baxter. Refer to Note 6 for further information.
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
Acquisition-related costs
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Sucampo
|
$
|
5.2
|
|
|
$
|
4.2
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Ocera
|
0.5
|
|
|
0.9
|
|
|
—
|
|
|
—
|
|
||||
InfaCare
|
—
|
|
|
1.2
|
|
|
—
|
|
|
—
|
|
||||
Stratatech
|
—
|
|
|
—
|
|
|
3.7
|
|
|
—
|
|
||||
Hemostasis
|
—
|
|
|
—
|
|
|
2.7
|
|
|
0.1
|
|
||||
Other
|
0.1
|
|
|
0.1
|
|
|
0.5
|
|
|
—
|
|
||||
Total acquisition-related costs
|
$
|
5.8
|
|
|
$
|
6.4
|
|
|
$
|
6.9
|
|
|
$
|
0.1
|
|
8.
|
Restructuring and Related Charges
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Specialty Brands
|
$
|
52.2
|
|
|
$
|
25.4
|
|
|
$
|
23.3
|
|
|
$
|
2.6
|
|
Specialty Generics and Amitiza
|
29.0
|
|
|
7.7
|
|
|
3.4
|
|
|
0.8
|
|
||||
Corporate
|
27.0
|
|
|
3.3
|
|
|
10.9
|
|
|
1.9
|
|
||||
Restructuring and related charges, net
|
108.2
|
|
|
36.4
|
|
|
37.6
|
|
|
5.3
|
|
||||
Less: accelerated depreciation
|
(5.2
|
)
|
|
(5.2
|
)
|
|
(4.9
|
)
|
|
(1.5
|
)
|
||||
Restructuring charges, net
|
$
|
103.0
|
|
|
$
|
31.2
|
|
|
$
|
32.7
|
|
|
$
|
3.8
|
|
|
|
|
|
|
|
|
|
||||||||
Charges in other income (expense) (1)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
0.6
|
|
|
$
|
—
|
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
2018 Mallinckrodt Program
|
$
|
5.2
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
2016 Mallinckrodt Program
|
71.6
|
|
|
36.2
|
|
|
8.3
|
|
|
5.2
|
|
||||
2013 Mallinckrodt Program
|
—
|
|
|
(0.7
|
)
|
|
25.6
|
|
|
—
|
|
||||
Acquisition programs
|
31.4
|
|
|
0.9
|
|
|
3.7
|
|
|
0.1
|
|
||||
Total programs
|
108.2
|
|
|
36.4
|
|
|
37.6
|
|
|
5.3
|
|
||||
Less: non-cash charges, including accelerated depreciation and impairments
|
(5.2
|
)
|
|
(5.2
|
)
|
|
(4.9
|
)
|
|
(1.5
|
)
|
||||
Total charges expected to be settled in cash
|
$
|
103.0
|
|
|
$
|
31.2
|
|
|
$
|
32.7
|
|
|
$
|
3.8
|
|
|
|
|
|
|
|
|
|
||||||||
Charges in other income (expense) (1)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
0.6
|
|
|
$
|
—
|
|
|
2018 Mallinckrodt Program
|
|
2016 Mallinckrodt Program
|
|
2013 Mallinckrodt Program
|
|
Acquisition Programs
|
|
Total
|
||||||||||
Balance at September 25, 2015
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
8.0
|
|
|
$
|
10.0
|
|
|
$
|
18.0
|
|
Charges from continuing operations
|
—
|
|
|
6.4
|
|
|
24.0
|
|
|
5.0
|
|
|
35.4
|
|
|||||
Charges from discontinued operations
|
—
|
|
|
—
|
|
|
2.5
|
|
|
—
|
|
|
2.5
|
|
|||||
Changes in estimate from continuing operations
|
—
|
|
|
—
|
|
|
(1.4
|
)
|
|
(1.3
|
)
|
|
(2.7
|
)
|
|||||
Changes in estimate from discontinued operations
|
—
|
|
|
—
|
|
|
(0.3
|
)
|
|
—
|
|
|
(0.3
|
)
|
|||||
Cash payments
|
—
|
|
|
(0.2
|
)
|
|
(20.3
|
)
|
|
(13.2
|
)
|
|
(33.7
|
)
|
|||||
Reclassifications (1)
|
—
|
|
|
—
|
|
|
(0.7
|
)
|
|
—
|
|
|
(0.7
|
)
|
|||||
Balance at September 30, 2016
|
—
|
|
|
6.2
|
|
|
11.8
|
|
|
0.5
|
|
|
18.5
|
|
|||||
Charges from continuing operations
|
—
|
|
|
3.7
|
|
|
—
|
|
|
0.1
|
|
|
3.8
|
|
|||||
Cash payments
|
—
|
|
|
(0.4
|
)
|
|
(6.7
|
)
|
|
(0.4
|
)
|
|
(7.5
|
)
|
|||||
Balance at December 30, 2016
|
—
|
|
|
9.5
|
|
|
5.1
|
|
|
0.2
|
|
|
14.8
|
|
|||||
Charges from continuing operations
|
—
|
|
|
35.8
|
|
|
—
|
|
|
0.9
|
|
|
36.7
|
|
|||||
Changes in estimate from continuing operations
|
—
|
|
|
(4.8
|
)
|
|
(0.7
|
)
|
|
—
|
|
|
(5.5
|
)
|
|||||
Cash payments
|
—
|
|
|
(26.1
|
)
|
|
(4.4
|
)
|
|
(0.3
|
)
|
|
(30.8
|
)
|
|||||
Reclassifications
|
—
|
|
|
0.3
|
|
|
—
|
|
|
—
|
|
|
0.3
|
|
|||||
Balance at December 29, 2017
|
—
|
|
|
14.7
|
|
|
—
|
|
|
0.8
|
|
|
15.5
|
|
|||||
Charges from continuing operations
|
2.2
|
|
|
76.9
|
|
|
—
|
|
|
29.9
|
|
|
109.0
|
|
|||||
Changes in estimate from continuing operations
|
—
|
|
|
(5.3
|
)
|
|
—
|
|
|
(0.7
|
)
|
|
(6.0
|
)
|
|||||
Cash payments
|
—
|
|
|
(23.4
|
)
|
|
—
|
|
|
(22.2
|
)
|
|
(45.6
|
)
|
|||||
Reclassifications
|
—
|
|
|
(1.9
|
)
|
|
—
|
|
|
—
|
|
|
(1.9
|
)
|
|||||
Balance at December 28, 2018
|
$
|
2.2
|
|
|
$
|
61.0
|
|
|
$
|
—
|
|
|
$
|
7.8
|
|
|
$
|
71.0
|
|
(1)
|
Represents the reclassification of pension and other postretirement benefits from restructuring reserves to pension and postretirement obligations.
|
|
2018 Mallinckrodt Program
|
|
2016 Mallinckrodt Program
|
|
2013 Mallinckrodt Program
|
||||||
Specialty Brands
|
$
|
3.0
|
|
|
$
|
81.7
|
|
|
$
|
18.8
|
|
Specialty Generics and Amitiza
|
—
|
|
|
14.6
|
|
|
18.3
|
|
|||
Discontinued Operations
|
—
|
|
|
—
|
|
|
69.9
|
|
|||
Corporate
|
2.2
|
|
|
25.9
|
|
|
17.7
|
|
|||
|
$
|
5.2
|
|
|
$
|
122.2
|
|
|
$
|
124.7
|
|
9.
|
Income Taxes
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
U.K.
|
$
|
(233.7
|
)
|
|
$
|
(165.9
|
)
|
|
$
|
(275.3
|
)
|
|
$
|
(97.4
|
)
|
Non-U.K.
|
(3,818.3
|
)
|
|
227.5
|
|
|
508.7
|
|
|
(201.1
|
)
|
||||
Total
|
$
|
(4,052.0
|
)
|
|
$
|
61.6
|
|
|
$
|
233.4
|
|
|
$
|
(298.5
|
)
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Current:
|
|
|
|
|
|
|
|
||||||||
U.K.
|
$
|
(0.2
|
)
|
|
$
|
0.4
|
|
|
$
|
0.3
|
|
|
$
|
—
|
|
Non-U.K.
|
113.0
|
|
|
37.7
|
|
|
120.5
|
|
|
82.0
|
|
||||
Current income tax provision
|
112.8
|
|
|
38.1
|
|
|
120.8
|
|
|
82.0
|
|
||||
Deferred:
|
|
|
|
|
|
|
|
||||||||
U.K.
|
1.4
|
|
|
0.6
|
|
|
0.7
|
|
|
(0.5
|
)
|
||||
Non-U.K.
|
(544.3
|
)
|
|
(1,748.3
|
)
|
|
(377.1
|
)
|
|
(203.2
|
)
|
||||
Deferred income tax benefit
|
(542.9
|
)
|
|
(1,747.7
|
)
|
|
(376.4
|
)
|
|
(203.7
|
)
|
||||
Total
|
$
|
(430.1
|
)
|
|
$
|
(1,709.6
|
)
|
|
$
|
(255.6
|
)
|
|
$
|
(121.7
|
)
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
(Benefit) provision for income taxes at U.K. statutory income tax rate (1)
|
$
|
(770.1
|
)
|
|
$
|
11.7
|
|
|
$
|
46.6
|
|
|
$
|
(59.7
|
)
|
Adjustments to reconcile to income tax provision:
|
|
|
|
|
|
|
|
||||||||
Rate difference between U.K. and non-U.K. jurisdictions (2) (4)
|
(235.7
|
)
|
|
(219.9
|
)
|
|
(249.3
|
)
|
|
(123.0
|
)
|
||||
Valuation allowances, nonrecurring
|
—
|
|
|
(3.7
|
)
|
|
2.1
|
|
|
—
|
|
||||
Adjustments to accrued income tax liabilities and uncertain tax positions
|
60.1
|
|
|
5.1
|
|
|
(14.9
|
)
|
|
0.9
|
|
||||
Interest and penalties on accrued income tax liabilities and uncertain tax positions
|
13.1
|
|
|
0.2
|
|
|
(16.4
|
)
|
|
(0.1
|
)
|
||||
Investment in partnership
|
—
|
|
|
—
|
|
|
—
|
|
|
(12.7
|
)
|
||||
Credits, principally research and orphan drug (3)
|
(25.9
|
)
|
|
(13.8
|
)
|
|
(33.7
|
)
|
|
(0.7
|
)
|
||||
Impairments non deductible
|
788.7
|
|
|
—
|
|
|
—
|
|
|
75.3
|
|
||||
Permanently nondeductible and nontaxable items
|
7.2
|
|
|
6.4
|
|
|
7.9
|
|
|
1.6
|
|
||||
Pension plan settlement, release of tax effects lodged in other comprehensive income
|
—
|
|
|
(2.4
|
)
|
|
—
|
|
|
—
|
|
||||
Divestitures (7)
|
(2.7
|
)
|
|
18.2
|
|
|
—
|
|
|
—
|
|
||||
U.S. Tax Reform (5)
|
(8.5
|
)
|
|
(456.9
|
)
|
|
—
|
|
|
—
|
|
||||
Legal Entity Reorganization (6)
|
(256.0
|
)
|
|
(1,054.8
|
)
|
|
—
|
|
|
—
|
|
||||
Other
|
(0.3
|
)
|
|
0.3
|
|
|
2.1
|
|
|
(3.3
|
)
|
||||
Benefit for income taxes
|
$
|
(430.1
|
)
|
|
$
|
(1,709.6
|
)
|
|
$
|
(255.6
|
)
|
|
$
|
(121.7
|
)
|
(1)
|
The statutory tax rate reflects the U.K. statutory tax rate of 19% for fiscal 2018 and 2017 and 20% for fiscal 2016 and the three months ended December 30, 2016.
|
(2)
|
Includes the impact of certain recurring valuation allowances for U.K. and non-U.K. jurisdictions.
|
(3)
|
During fiscal 2018, the research and orphan drug credits increased in conjunction with the Company's increased investment in qualified research. During fiscal 2016, the Company realized a tax benefit of $27.4 million resulting from a U.K. tax credit on a dividend between affiliates.
|
(4)
|
During the three months ended December 30, 2016, the rate difference between U.K. and non-U.K. jurisdictions was favorably impacted by a benefit of $16.1 million on a $102.0 million settlement with the Federal Trade Commission and a benefit of $34.5 million on a $207.0 million goodwill impairment in the Specialty Generics reporting unit.
|
(5)
|
For fiscal 2018, the Company completed its analysis of the TCJA and recognized an additional tax benefit. Other line items, to the extent U.S. related, are reflected at the current U.S. statutory income tax rate of 21%. For fiscal 2017, the benefit reflects the redetermination of the Company’s end of year net deferred tax liabilities as a result of the new U.S. statutory income tax rate of 21%. Other line items, to the extent U.S. related, are reflected at the former U.S. statutory income tax rate of 35%.
|
(6)
|
Associated unrecognized tax benefit netted within this line.
|
(7)
|
During fiscal 2018, the Company completed the sale of a portion of its Hemostasis business. During fiscal 2017, the Company completed the sale of the Intrathecal Therapy Business.
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Balance at beginning of period
|
$
|
182.5
|
|
|
$
|
118.7
|
|
|
$
|
89.2
|
|
|
$
|
114.8
|
|
Additions related to current year tax positions
|
19.6
|
|
|
79.9
|
|
|
63.8
|
|
|
5.0
|
|
||||
Additions related to prior period tax positions
|
125.1
|
|
|
0.3
|
|
|
10.8
|
|
|
—
|
|
||||
Reductions related to prior period tax positions
|
(32.7
|
)
|
|
(13.6
|
)
|
|
(37.8
|
)
|
|
(1.1
|
)
|
||||
Reductions related to disposition transactions
|
—
|
|
|
—
|
|
|
(6.6
|
)
|
|
—
|
|
||||
Settlements
|
(2.0
|
)
|
|
—
|
|
|
(2.6
|
)
|
|
—
|
|
||||
Lapse of statute of limitations
|
(4.8
|
)
|
|
(2.8
|
)
|
|
(2.0
|
)
|
|
—
|
|
||||
Balance at end of period
|
$
|
287.7
|
|
|
$
|
182.5
|
|
|
$
|
114.8
|
|
|
$
|
118.7
|
|
|
December 28, 2018
|
|
December 29, 2017
|
||||
Accrued and other current liabilities
|
$
|
1.0
|
|
|
$
|
1.5
|
|
Other income tax liabilities
|
189.9
|
|
|
82.6
|
|
||
Deferred income taxes (non-current liability)
|
96.8
|
|
|
98.4
|
|
||
|
$
|
287.7
|
|
|
$
|
182.5
|
|
|
December 28, 2018
|
|
December 29, 2017
|
||||
Income taxes payable
|
$
|
25.0
|
|
|
$
|
15.8
|
|
Other income tax liabilities
|
228.0
|
|
|
94.1
|
|
||
|
$
|
253.0
|
|
|
$
|
109.9
|
|
|
December 28, 2018
|
|
December 29, 2017
|
||||
Other assets
|
$
|
3.0
|
|
|
$
|
—
|
|
Prepaid expenses and other current assets
|
16.2
|
|
|
6.1
|
|
||
|
$
|
19.2
|
|
|
$
|
6.1
|
|
|
December 28, 2018
|
|
December 29, 2017
|
||||
Deferred tax assets:
|
|
|
|
||||
Accrued liabilities and reserves
|
$
|
56.3
|
|
|
$
|
62.7
|
|
Tax loss and credit carryforwards
|
1,987.8
|
|
|
1,734.5
|
|
||
Intangible assets
|
757.7
|
|
|
575.1
|
|
||
Other
|
204.6
|
|
|
113.3
|
|
||
|
3,006.4
|
|
|
2,485.6
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Intangible assets
|
(264.7
|
)
|
|
(181.0
|
)
|
||
Interest-bearing deferred tax obligations
|
(227.5
|
)
|
|
(553.5
|
)
|
||
Investment in partnership
|
(170.2
|
)
|
|
(108.8
|
)
|
||
Other
|
(42.9
|
)
|
|
(47.0
|
)
|
||
|
(705.3
|
)
|
|
(890.3
|
)
|
||
Net deferred tax asset before valuation allowances
|
2,301.1
|
|
|
1,595.3
|
|
||
Valuation allowances
|
(2,604.9
|
)
|
|
(2,267.9
|
)
|
||
Net deferred tax liability
|
$
|
(303.8
|
)
|
|
$
|
(672.6
|
)
|
|
December 28, 2018
|
|
December 29, 2017
|
||||
Other assets
|
$
|
20.5
|
|
|
$
|
16.4
|
|
Deferred income taxes (non-current liability)
|
(324.3
|
)
|
|
(689.0
|
)
|
||
Net deferred tax liability
|
$
|
(303.8
|
)
|
|
$
|
(672.6
|
)
|
10.
|
(Loss) Earnings per Share
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
(Loss) earnings per share numerator:
|
|
|
|
|
|
|
|
||||||||
(Loss) income from continuing operations attributable to common shareholders
|
$
|
(3,621.9
|
)
|
|
$
|
1,771.2
|
|
|
$
|
489.0
|
|
|
$
|
(176.8
|
)
|
Income from discontinued operations
|
14.9
|
|
|
363.2
|
|
|
154.7
|
|
|
23.6
|
|
||||
Net (loss) income attributable to common shareholders
|
$
|
(3,607.0
|
)
|
|
$
|
2,134.4
|
|
|
$
|
643.7
|
|
|
$
|
(153.2
|
)
|
(Loss) earnings per share denominator:
|
|
|
|
|
|
|
|
||||||||
Weighted-average shares outstanding - basic
|
84.0
|
|
|
97.7
|
|
|
110.6
|
|
|
105.7
|
|
||||
Impact of dilutive securities
|
—
|
|
|
0.2
|
|
|
0.9
|
|
|
—
|
|
||||
Weighted-average shares outstanding - diluted
|
84.0
|
|
|
97.9
|
|
|
111.5
|
|
|
105.7
|
|
||||
Basic (loss) earnings per share attributable to common shareholders:
|
|
|
|
|
|
|
|
||||||||
(Loss) income from continuing operations
|
$
|
(43.12
|
)
|
|
$
|
18.13
|
|
|
$
|
4.42
|
|
|
$
|
(1.67
|
)
|
Income from discontinued operations
|
0.18
|
|
|
3.72
|
|
|
1.40
|
|
|
0.22
|
|
||||
Net (loss) income attributable to common shareholders
|
$
|
(42.94
|
)
|
|
$
|
21.85
|
|
|
$
|
5.82
|
|
|
$
|
(1.45
|
)
|
Diluted (loss) earnings per share attributable to common shareholders:
|
|
|
|
|
|
|
|
||||||||
(Loss) income from continuing operations
|
$
|
(43.12
|
)
|
|
$
|
18.09
|
|
|
$
|
4.39
|
|
|
$
|
(1.67
|
)
|
Income from discontinued operations
|
0.18
|
|
|
3.71
|
|
|
1.39
|
|
|
0.22
|
|
||||
Net (loss) income attributable to common shareholders
|
$
|
(42.94
|
)
|
|
$
|
21.80
|
|
|
$
|
5.77
|
|
|
$
|
(1.45
|
)
|
11.
|
Inventories
|
|
December 28,
2018 |
|
December 29,
2017 |
||||
Raw materials and supplies
|
$
|
69.2
|
|
|
$
|
70.0
|
|
Work in process
|
167.6
|
|
|
167.1
|
|
||
Finished goods
|
85.5
|
|
|
103.3
|
|
||
Inventories
|
$
|
322.3
|
|
|
$
|
340.4
|
|
12.
|
Property, Plant and Equipment
|
|
December 28, 2018
|
|
December 29, 2017
|
||||
Land
|
$
|
43.9
|
|
|
$
|
44.0
|
|
Buildings
|
379.5
|
|
|
355.5
|
|
||
Capitalized software
|
130.8
|
|
|
109.0
|
|
||
Machinery and equipment
|
1,137.3
|
|
|
1,123.8
|
|
||
Construction in process
|
244.7
|
|
|
209.7
|
|
||
|
1,936.2
|
|
|
1,842.0
|
|
||
Less: accumulated depreciation
|
(954.2
|
)
|
|
(875.2
|
)
|
||
Property, plant and equipment, net
|
$
|
982.0
|
|
|
$
|
966.8
|
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Depreciation expense
|
$
|
111.9
|
|
|
$
|
113.8
|
|
|
$
|
113.3
|
|
|
$
|
27.5
|
|
13.
|
Goodwill and Intangible Assets
|
|
December 28, 2018
|
|
December 29, 2017
|
||||||||||||
|
Gross Carrying amount
|
|
Accumulated Impairment
|
|
Gross Carrying amount
|
|
Accumulated Impairment
|
||||||||
Specialty Brands
|
$
|
3,672.8
|
|
|
$
|
(3,672.8
|
)
|
|
$
|
3,482.7
|
|
|
$
|
—
|
|
Specialty Generics
|
207.0
|
|
|
(207.0
|
)
|
|
207.0
|
|
|
(207.0
|
)
|
||||
Total
|
$
|
3,879.8
|
|
|
|
($3,879.8
|
)
|
|
$
|
3,689.7
|
|
|
$
|
(207.0
|
)
|
|
December 28, 2018
|
|
December 29, 2017
|
||||||||||||
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
||||||||
Amortizable:
|
|
|
|
|
|
|
|
||||||||
Completed technology
|
$
|
10,467.9
|
|
|
$
|
2,980.6
|
|
|
$
|
9,882.8
|
|
|
$
|
2,260.8
|
|
License agreements
|
120.1
|
|
|
70.1
|
|
|
177.1
|
|
|
121.1
|
|
||||
Trademarks
|
81.9
|
|
|
18.1
|
|
|
82.1
|
|
|
14.5
|
|
||||
Customer relationships
|
27.5
|
|
|
14.1
|
|
|
29.5
|
|
|
12.2
|
|
||||
Other
|
—
|
|
|
—
|
|
|
8.6
|
|
|
8.6
|
|
||||
Total
|
$
|
10,697.4
|
|
|
$
|
3,082.9
|
|
|
$
|
10,180.1
|
|
|
$
|
2,417.2
|
|
Non-Amortizable:
|
|
|
|
|
|
|
|
||||||||
Trademarks
|
$
|
35.0
|
|
|
|
|
$
|
35.0
|
|
|
|
||||
In-process research and development
|
633.3
|
|
|
|
|
577.1
|
|
|
|
||||||
Total
|
$
|
668.3
|
|
|
|
|
$
|
612.1
|
|
|
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Amortization expense
|
$
|
740.2
|
|
|
$
|
694.5
|
|
|
$
|
700.1
|
|
|
$
|
175.7
|
|
Fiscal 2019
|
$
|
748.4
|
|
Fiscal 2020
|
748.0
|
|
|
Fiscal 2021
|
747.8
|
|
|
Fiscal 2022
|
620.8
|
|
|
Fiscal 2023
|
584.8
|
|
14.
|
Debt
|
|
December 28, 2018
|
|
December 29, 2017
|
||||||||||||
|
Principal
|
|
Unamortized Discount and Debt Issuance Costs
|
|
Principal
|
|
Unamortized Discount and Debt Issuance Costs
|
||||||||
Current maturities of long-term debt:
|
|
|
|
|
|
|
|
||||||||
3.50% notes due April 2018
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
300.0
|
|
|
$
|
0.2
|
|
Term loan due September 2024
|
16.4
|
|
|
0.2
|
|
|
14.0
|
|
|
0.3
|
|
||||
Term loan due February 2025
|
6.0
|
|
|
0.1
|
|
|
—
|
|
|
—
|
|
||||
Other
|
0.3
|
|
|
—
|
|
|
0.2
|
|
|
—
|
|
||||
Total current debt
|
22.7
|
|
|
0.3
|
|
|
314.2
|
|
|
0.5
|
|
||||
Long-term debt:
|
|
|
|
|
|
|
|
||||||||
4.875% notes due April 2020
|
700.0
|
|
|
3.2
|
|
|
700.0
|
|
|
5.7
|
|
||||
Variable-rate receivable securitization due July 2020
|
250.0
|
|
|
0.4
|
|
|
200.0
|
|
|
0.7
|
|
||||
9.50% debentures due May 2022
|
10.4
|
|
|
—
|
|
|
10.4
|
|
|
—
|
|
||||
5.75% notes due August 2022
|
835.2
|
|
|
7.0
|
|
|
884.0
|
|
|
9.5
|
|
||||
8.00% debentures due March 2023
|
4.4
|
|
|
—
|
|
|
4.4
|
|
|
—
|
|
||||
4.75% notes due April 2023
|
500.2
|
|
|
3.5
|
|
|
526.5
|
|
|
4.5
|
|
||||
5.625% notes due October 2023
|
731.4
|
|
|
8.0
|
|
|
738.0
|
|
|
9.7
|
|
||||
Term loan due September 2024
|
1,597.4
|
|
|
19.8
|
|
|
1,837.2
|
|
|
26.7
|
|
||||
Term loan due February 2025
|
591.0
|
|
|
10.7
|
|
|
—
|
|
|
—
|
|
||||
5.50% notes due April 2025
|
692.1
|
|
|
7.7
|
|
|
692.1
|
|
|
9.0
|
|
||||
Other
|
1.9
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Revolving credit facility
|
220.0
|
|
|
4.5
|
|
|
900.0
|
|
|
5.9
|
|
||||
Total long-term debt
|
6,134.0
|
|
|
64.8
|
|
|
6,492.6
|
|
|
71.7
|
|
||||
Total debt
|
$
|
6,156.7
|
|
|
$
|
65.1
|
|
|
$
|
6,806.8
|
|
|
$
|
72.2
|
|
|
Applicable interest rate
|
|
Outstanding borrowings
|
|||
Term loan due September 2024
|
5.14
|
%
|
|
$
|
1,613.8
|
|
Term loan due February 2025
|
5.62
|
%
|
|
597.0
|
|
|
Variable-rate receivable securitization
|
3.22
|
%
|
|
250.0
|
|
|
Revolving credit facility
|
4.64
|
%
|
|
220.0
|
|
Fiscal 2019
|
$
|
22.7
|
|
Fiscal 2020
|
972.7
|
|
|
Fiscal 2021
|
28.2
|
|
|
Fiscal 2022
|
1,088.2
|
|
|
Fiscal 2023
|
1,258.6
|
|
15.
|
Retirement Plans
|
|
Pension Benefits
|
||||||||||||||
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28,
2018 |
|
December 29,
2017 |
|
September 30,
2016 |
|
December 30,
2016 |
||||||||
Service cost
|
$
|
0.2
|
|
|
$
|
1.4
|
|
|
$
|
1.8
|
|
|
$
|
0.8
|
|
Interest cost
|
0.6
|
|
|
2.3
|
|
|
13.2
|
|
|
2.0
|
|
||||
Expected return on plan assets
|
—
|
|
|
(1.3
|
)
|
|
(16.7
|
)
|
|
(2.3
|
)
|
||||
Amortization of net actuarial loss
|
0.5
|
|
|
2.7
|
|
|
11.3
|
|
|
3.5
|
|
||||
Amortization of prior service cost
|
0.1
|
|
|
0.2
|
|
|
—
|
|
|
0.1
|
|
||||
Loss on plan settlements
|
0.1
|
|
|
71.1
|
|
|
8.1
|
|
|
45.0
|
|
||||
Curtailment gain
|
—
|
|
|
(1.0
|
)
|
|
—
|
|
|
—
|
|
||||
Net periodic benefit cost
|
$
|
1.5
|
|
|
$
|
75.4
|
|
|
$
|
17.7
|
|
|
$
|
49.1
|
|
|
Postretirement Benefits
|
||||||||||||||
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28,
2018 |
|
December 29,
2017 |
|
September 30,
2016 |
|
December 30,
2016 |
||||||||
Service cost
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
0.1
|
|
|
$
|
0.1
|
|
Interest cost
|
1.5
|
|
|
1.7
|
|
|
2.0
|
|
|
0.4
|
|
||||
Amortization of net actuarial loss
|
0.1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Amortization of prior service credit
|
(2.1
|
)
|
|
(2.0
|
)
|
|
(2.1
|
)
|
|
(0.5
|
)
|
||||
Gain on plan settlements
|
(0.7
|
)
|
|
(0.9
|
)
|
|
—
|
|
|
—
|
|
||||
Net periodic benefit credit
|
$
|
(1.2
|
)
|
|
$
|
(1.2
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Pension Benefits
|
|
Postretirement Benefits
|
||||||||||||
|
December 28,
2018 |
|
December 29,
2017 |
|
December 28,
2018 |
|
December 29,
2017 |
||||||||
Change in benefit obligations:
|
|
|
|
|
|
|
|
||||||||
Projected benefit obligations at beginning of year
|
$
|
27.8
|
|
|
$
|
257.4
|
|
|
$
|
45.6
|
|
|
$
|
47.5
|
|
Service cost
|
0.2
|
|
|
1.4
|
|
|
—
|
|
|
—
|
|
||||
Interest cost
|
0.6
|
|
|
2.3
|
|
|
1.5
|
|
|
1.7
|
|
||||
Actuarial loss (gain)
|
0.7
|
|
|
(9.0
|
)
|
|
(3.9
|
)
|
|
0.2
|
|
||||
Benefits and administrative expenses paid
|
(1.6
|
)
|
|
(9.4
|
)
|
|
(2.7
|
)
|
|
(2.9
|
)
|
||||
Plan settlements
|
(0.8
|
)
|
|
(217.0
|
)
|
|
(0.7
|
)
|
|
(0.9
|
)
|
||||
Currency translation
|
(0.8
|
)
|
|
2.1
|
|
|
—
|
|
|
—
|
|
||||
Projected benefit obligations at end of year
|
26.1
|
|
|
27.8
|
|
|
39.8
|
|
|
45.6
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Change in plan assets:
|
|
|
|
|
|
|
|
||||||||
Fair value of plan assets at beginning of year
|
—
|
|
|
161.0
|
|
|
—
|
|
|
—
|
|
||||
Actual return on plan assets
|
—
|
|
|
0.3
|
|
|
—
|
|
|
—
|
|
||||
Employer contributions
|
2.4
|
|
|
68.0
|
|
|
2.7
|
|
|
2.9
|
|
||||
Benefits and administrative expenses paid
|
(1.6
|
)
|
|
(9.4
|
)
|
|
(2.7
|
)
|
|
(2.9
|
)
|
||||
Plan settlements
|
(0.8
|
)
|
|
(217.0
|
)
|
|
—
|
|
|
—
|
|
||||
Net transfer out
|
—
|
|
|
(2.9
|
)
|
|
—
|
|
|
—
|
|
||||
Fair value of plan assets at end of year
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Funded status at end of year
|
$
|
(26.1
|
)
|
|
$
|
(27.8
|
)
|
|
$
|
(39.8
|
)
|
|
$
|
(45.6
|
)
|
|
Pension Benefits
|
|
Postretirement Benefits
|
||||||||||||
|
December 28,
2018 |
|
December 29,
2017 |
|
December 28,
2018 |
|
December 29,
2017 |
||||||||
Amounts recognized on the consolidated balance sheet:
|
|
|
|
|
|
|
|
||||||||
Current liabilities
|
$
|
(2.0
|
)
|
|
$
|
(2.4
|
)
|
|
$
|
(3.4
|
)
|
|
$
|
(3.9
|
)
|
Non-current liabilities
|
(24.1
|
)
|
|
(25.4
|
)
|
|
(36.4
|
)
|
|
(41.7
|
)
|
||||
Net amount recognized on the consolidated balance sheet
|
$
|
(26.1
|
)
|
|
$
|
(27.8
|
)
|
|
$
|
(39.8
|
)
|
|
$
|
(45.6
|
)
|
|
|
|
|
|
|
|
|
||||||||
Amounts recognized in accumulated other comprehensive loss consist of:
|
|
|
|
|
|
|
|
||||||||
Net actuarial (loss) gain
|
$
|
(8.4
|
)
|
|
$
|
(8.6
|
)
|
|
$
|
0.9
|
|
|
$
|
(3.0
|
)
|
Prior service (cost) credit
|
(0.4
|
)
|
|
(0.5
|
)
|
|
8.1
|
|
|
10.2
|
|
||||
Net amount recognized in accumulated other comprehensive loss
|
$
|
(8.8
|
)
|
|
$
|
(9.1
|
)
|
|
$
|
9.0
|
|
|
$
|
7.2
|
|
|
Pension Benefits
|
|
Postretirement Benefits
|
||||
Amortization of net actuarial loss
|
$
|
0.5
|
|
|
$
|
—
|
|
Amortization of prior service cost (credit)
|
0.1
|
|
|
(2.1
|
)
|
|
December 28,
2018 |
|
December 29,
2017 |
||||
Pension plans with accumulated benefit obligations in excess of plan assets:
|
|
|
|
||||
Accumulated benefit obligation
|
$
|
25.6
|
|
|
$
|
27.3
|
|
|
U.S. Plans
|
|
Non-U.S. Plans
|
||||||||||||||||||||
|
Fiscal Year Ended
|
|
Three Months Ended
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Discount rate
|
3.3
|
%
|
|
3.0
|
%
|
|
3.9
|
%
|
|
2.2
|
%
|
|
1.9
|
%
|
|
1.8
|
%
|
|
2.0
|
%
|
|
1.3
|
%
|
Expected return on plan assets
|
—
|
%
|
|
3.5
|
%
|
|
5.8
|
%
|
|
3.5
|
%
|
|
—
|
%
|
|
—
|
%
|
|
2.0
|
%
|
|
—
|
%
|
Rate of compensation increase
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
2.5
|
%
|
|
2.5
|
%
|
|
—
|
%
|
|
—
|
%
|
|
U.S. Plans
|
|
Non-U.S. Plans
|
||||||||||||||||||||
|
Fiscal Year Ended
|
|
Three Months Ended
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Discount rate
|
4.0
|
%
|
|
3.3
|
%
|
|
2.3
|
%
|
|
3.0
|
%
|
|
2.0
|
%
|
|
1.9
|
%
|
|
1.3
|
%
|
|
1.8
|
%
|
Rate of compensation increase
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
2.5
|
%
|
|
2.5
|
%
|
|
—
|
%
|
|
0.3
|
%
|
|
Fiscal Year
|
|
Three Months Ended
|
||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||
Net periodic benefit cost
|
3.4
|
%
|
|
3.7
|
%
|
|
4.0
|
%
|
|
3.2
|
%
|
Benefit obligations
|
4.1
|
%
|
|
3.4
|
%
|
|
3.2
|
%
|
|
3.8
|
%
|
|
December 28,
2018 |
|
December 29,
2017 |
||
Healthcare cost trend rate assumed for next fiscal year
|
6.3
|
%
|
|
6.9
|
%
|
Rate to which the cost trend rate is assumed to decline
|
4.5
|
%
|
|
4.5
|
%
|
Fiscal year the ultimate trend rate is achieved
|
2038
|
|
|
2038
|
|
|
One-Percentage-Point Increase
|
|
One-Percentage-Point Decrease
|
||||
Effect on total of service and interest cost
|
$
|
—
|
|
|
$
|
—
|
|
Effect on postretirement benefit obligation
|
0.2
|
|
|
(0.2
|
)
|
|
Pension Benefits
|
|
Postretirement Benefits
|
||||
Fiscal 2019
|
$
|
2.0
|
|
|
$
|
3.5
|
|
Fiscal 2020
|
1.7
|
|
|
3.4
|
|
||
Fiscal 2021
|
1.7
|
|
|
3.2
|
|
||
Fiscal 2022
|
1.6
|
|
|
3.1
|
|
||
Fiscal 2023
|
1.6
|
|
|
3.0
|
|
||
Fiscal 2024 - 2028
|
7.4
|
|
|
13.4
|
|
16.
|
Equity
|
|
March 2017 Repurchase Program
|
|
March 2016
Repurchase Program |
|
November 2015 Repurchase Program
|
|
January 2015
Repurchase Program
|
||||||||||||||||||||
|
Number of Shares
|
|
Amount
|
|
Number of Shares
|
|
Amount
|
|
Number of Shares
|
|
Amount
|
|
Number of Shares
|
|
Amount
|
||||||||||||
Authorized repurchase amount
|
|
|
$
|
1,000.0
|
|
|
|
|
$
|
350.0
|
|
|
|
|
$
|
500.0
|
|
|
|
|
|
$
|
300.0
|
|
|||
Repurchases:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Fiscal 2015
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
823,592
|
|
|
75.0
|
|
||||
Fiscal 2016
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,510,824
|
|
|
425.6
|
|
|
3,199,279
|
|
|
225.0
|
|
||||
Three months ended December 30, 2016
|
—
|
|
|
—
|
|
|
1,501,676
|
|
|
84.0
|
|
|
1,063,337
|
|
|
74.4
|
|
|
—
|
|
|
—
|
|
||||
Fiscal 2017
|
13,490,448
|
|
|
380.6
|
|
|
5,366,741
|
|
|
266.0
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Fiscal 2018
|
3,610,968
|
|
|
55.2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Remaining amount available
|
|
|
$
|
564.2
|
|
|
|
|
$
|
—
|
|
|
|
|
$
|
—
|
|
|
|
|
$
|
—
|
|
17.
|
Share Plans
|
|
|
Maximum Number of Common Shares to be Issued as Awards (in millions)
|
|
2013 Plan
|
|
5.7
|
|
2015 Plan
|
|
17.8
|
|
2018 Plan
|
|
26.8
|
|
|
Share Options
|
|
Weighted-Average Exercise Price
|
|
Weighted-Average Remaining Contractual Term
(in years) |
|
Aggregate Intrinsic Value
|
|||||
Outstanding at September 25, 2015
|
2,786,443
|
|
|
$
|
52.76
|
|
|
|
|
|
||
Granted
|
1,248,828
|
|
|
72.44
|
|
|
|
|
|
|||
Exercised
|
(413,830
|
)
|
|
32.76
|
|
|
|
|
|
|||
Expired/Forfeited
|
(199,585
|
)
|
|
72.65
|
|
|
|
|
|
|||
Outstanding at September 30, 2016
|
3,421,856
|
|
|
61.17
|
|
|
|
|
|
|||
Granted
|
3,742
|
|
|
60.01
|
|
|
|
|
|
|||
Exercised
|
(16,382
|
)
|
|
36.42
|
|
|
|
|
|
|||
Expired/Forfeited
|
(22,522
|
)
|
|
70.82
|
|
|
|
|
|
|||
Outstanding at December 30, 2016
|
3,386,694
|
|
|
61.24
|
|
|
|
|
|
|||
Granted
|
1,719,532
|
|
|
51.57
|
|
|
|
|
|
|||
Exercised
|
(113,605
|
)
|
|
47.74
|
|
|
|
|
|
|||
Expired/Forfeited
|
(348,637
|
)
|
|
68.08
|
|
|
|
|
|
|||
Outstanding at December 29, 2017
|
4,643,984
|
|
|
57.78
|
|
|
|
|
|
|||
Granted
|
3,159,521
|
|
|
13.92
|
|
|
|
|
|
|||
Exercised
|
(39,949
|
)
|
|
32.00
|
|
|
|
|
|
|||
Expired/Forfeited
|
(756,505
|
)
|
|
52.63
|
|
|
|
|
|
|||
Outstanding at December 28, 2018
|
7,007,051
|
|
|
38.74
|
|
|
4.8
|
|
$
|
6.5
|
|
|
|
|
|
|
|
|
|
|
|||||
Vested and non-vested expected to vest as of December 28, 2018
|
6,114,782
|
|
|
39.94
|
|
|
7.6
|
|
$
|
5.5
|
|
|
Exercisable at December 28, 2018
|
2,414,968
|
|
|
55.24
|
|
|
4.9
|
|
0.1
|
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Expected share price volatility
|
38
|
%
|
|
36
|
%
|
|
31
|
%
|
|
35
|
%
|
||||
Risk-free interest rate
|
2.64
|
%
|
|
2.00
|
%
|
|
1.74
|
%
|
|
1.23
|
%
|
||||
Expected annual dividend per share
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
||||
Expected life of options (in years)
|
5.3
|
|
|
5.3
|
|
|
5.3
|
|
|
5.3
|
|
||||
Fair value per option
|
$
|
5.32
|
|
|
$
|
18.36
|
|
|
$
|
22.82
|
|
|
$
|
20.04
|
|
|
Shares
|
|
Weighted-Average
Grant-Date Fair Value |
|||
Non-vested at September 25, 2015
|
572,494
|
|
|
$
|
73.45
|
|
Granted
|
615,074
|
|
|
70.10
|
|
|
Vested
|
(193,849
|
)
|
|
69.27
|
|
|
Expired/Forfeited
|
(99,260
|
)
|
|
79.95
|
|
|
Non-vested at September 30, 2016
|
894,459
|
|
|
70.40
|
|
|
Granted
|
36,731
|
|
|
69.08
|
|
|
Exercised
|
(30,919
|
)
|
|
47.54
|
|
|
Expired/Forfeited
|
(16,809
|
)
|
|
49.62
|
|
|
Non-vested at December 30, 2016
|
883,462
|
|
|
71.03
|
|
|
Granted
|
655,282
|
|
|
50.74
|
|
|
Exercised
|
(263,189
|
)
|
|
69.14
|
|
|
Expired/Forfeited
|
(169,789
|
)
|
|
68.57
|
|
|
Non-vested at December 29, 2017
|
1,105,766
|
|
|
60.08
|
|
|
Granted
|
1,222,568
|
|
|
14.58
|
|
|
Exercised
|
(433,354
|
)
|
|
57.93
|
|
|
Expired/Forfeited
|
(209,879
|
)
|
|
44.38
|
|
|
Non-vested at December 28, 2018
|
1,685,101
|
|
|
29.54
|
|
|
Shares
|
|
Weighted-Average
Grant-Date Fair Value |
|||
Non-vested at September 25, 2015
|
130,974
|
|
|
$
|
96.05
|
|
Granted
|
145,192
|
|
|
83.00
|
|
|
Forfeited
|
(9,521
|
)
|
|
96.30
|
|
|
Non-vested at September 30, 2016
|
266,645
|
|
|
88.59
|
|
|
Forfeited
|
(997
|
)
|
|
154.42
|
|
|
Non-vested at December 30, 2016
|
265,648
|
|
|
88.51
|
|
|
Granted
|
348,963
|
|
|
51.73
|
|
|
Forfeited
|
(48,606
|
)
|
|
107.00
|
|
|
Vested
|
(61,554
|
)
|
|
62.65
|
|
|
Non-vested at December 29, 2017
|
504,451
|
|
|
64.44
|
|
|
Granted
|
770,714
|
|
|
13.80
|
|
|
Forfeited
|
(89,614
|
)
|
|
59.18
|
|
|
Vested
|
(24,022
|
)
|
|
98.27
|
|
|
Non-vested at December 28, 2018
|
1,161,529
|
|
|
28.61
|
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||
Expected stock price volatility
|
57
|
%
|
|
48
|
%
|
|
41
|
%
|
|
48
|
%
|
Peer group stock price volatility
|
39
|
%
|
|
40
|
%
|
|
36
|
%
|
|
40
|
%
|
Correlation of returns
|
2
|
%
|
|
17
|
%
|
|
24
|
%
|
|
17
|
%
|
|
Shares
|
|
Non-vested at September 25, 2015
|
34,562
|
|
Vested
|
(9,760
|
)
|
Forfeited
|
(7,936
|
)
|
Non-vested at September 30, 2016
|
16,866
|
|
Vested
|
(1,087
|
)
|
Forfeited
|
(911
|
)
|
Non-vested at December 30, 2016
|
14,868
|
|
Vested
|
(7,970
|
)
|
Forfeited
|
(2,223
|
)
|
Non-vested at December 29, 2017
|
4,675
|
|
Vested
|
(3,970
|
)
|
Forfeited
|
(705
|
)
|
Non-vested at December 28, 2018
|
—
|
|
18.
|
Accumulated Other Comprehensive Loss
|
|
Currency Translation
|
|
Unrecognized Loss on Derivatives
|
|
Unrecognized (Loss) Gain on Benefit Plans
|
|
Unrecognized Gain on Equity Securities (1)
|
|
Accumulated Other Comprehensive Loss (1)
|
||||||||||
Balance at December 30, 2016
|
$
|
(19.5
|
)
|
|
$
|
(5.7
|
)
|
|
$
|
(47.3
|
)
|
|
$
|
—
|
|
|
$
|
(72.5
|
)
|
Other comprehensive income, net
|
16.0
|
|
|
—
|
|
|
5.2
|
|
|
1.5
|
|
|
22.7
|
|
|||||
Reclassification from other comprehensive (loss) income
|
(4.7
|
)
|
|
1.0
|
|
|
40.6
|
|
|
(1.5
|
)
|
|
35.4
|
|
|||||
Balance at December 29, 2017
|
(8.2
|
)
|
|
(4.7
|
)
|
|
(1.5
|
)
|
|
—
|
|
|
(14.4
|
)
|
|||||
Other comprehensive (loss) income, net
|
(12.2
|
)
|
|
—
|
|
|
3.1
|
|
|
—
|
|
|
(9.1
|
)
|
|||||
Reclassification from other comprehensive income (loss)
|
—
|
|
|
0.7
|
|
|
(1.5
|
)
|
|
—
|
|
|
(0.8
|
)
|
|||||
Balance at December 28, 2018
|
$
|
(20.4
|
)
|
|
$
|
(4.0
|
)
|
|
$
|
0.1
|
|
|
$
|
—
|
|
|
$
|
(24.3
|
)
|
(1)
|
Upon adoption of ASU 2016-01, a reclassification of $1.5 million relating to the unrealized gain on investment resulted in an increase to beginning retained earnings with an offsetting decrease to accumulated other comprehensive loss. See Note 4 for additional details.
|
|
Amount Reclassified From Accumulated Other Comprehensive Loss
|
|
|
||||||
|
December 28,
2018
|
|
December 29,
2017
|
|
Line Item in the Consolidated
Statement of Income |
||||
Currency translation
|
$
|
—
|
|
|
$
|
(4.7
|
)
|
|
|
|
|
|
|
|
|
||||
Amortization of unrealized loss on derivatives
|
0.9
|
|
|
1.3
|
|
|
Interest expense
|
||
Income tax provision
|
(0.2
|
)
|
|
(0.3
|
)
|
|
Provision for income taxes
|
||
Net of income taxes
|
0.7
|
|
|
1.0
|
|
|
|
||
|
|
|
|
|
|
||||
Amortization of pension and post-retirement benefit plans:
|
|
|
|
|
|
||||
Net actuarial loss
|
0.6
|
|
|
2.7
|
|
|
(1)
|
||
Prior service credit
|
(2.0
|
)
|
|
(1.9
|
)
|
|
(1)
|
||
Disposal of discontinued operations
|
—
|
|
|
(3.1
|
)
|
|
|
||
Plan settlements
|
(0.6
|
)
|
|
70.2
|
|
|
(1)
|
||
Total before tax
|
(2.0
|
)
|
|
67.9
|
|
|
|
||
Income tax effect
|
0.5
|
|
|
(27.3
|
)
|
|
Provision for income taxes
|
||
Net of income taxes
|
(1.5
|
)
|
|
40.6
|
|
|
|
||
|
|
|
|
|
|
||||
Recognized gain on equity securities (2)
|
—
|
|
|
(1.5
|
)
|
|
|
||
|
|
|
|
|
|
||||
Total reclassifications for the period
|
$
|
(0.8
|
)
|
|
$
|
35.4
|
|
|
|
(1)
|
These accumulated other comprehensive loss components are included in the computation of net periodic benefit cost. See Note 15 for additional details.
|
(2)
|
Upon adoption of ASU 2016-01, a reclassification of $1.5 million relating to the unrealized gain on investment resulted in an increase to beginning retained earnings with an offsetting decrease to accumulated other comprehensive loss. See Note 4 for additional details.
|
19.
|
Guarantees
|
20.
|
Commitments and Contingencies
|
|
Operating Leases
|
||
Fiscal 2019
|
$
|
22.3
|
|
Fiscal 2020
|
16.4
|
|
|
Fiscal 2021
|
12.8
|
|
|
Fiscal 2022
|
10.6
|
|
|
Fiscal 2023
|
10.3
|
|
|
Thereafter
|
39.2
|
|
|
Total minimum lease payments
|
$
|
111.6
|
|
21.
|
Financial Instruments and Fair Value Measurements
|
|
December 28,
2018 |
|
Quoted Prices in Active Markets for Identical Assets
(Level 1) |
|
Significant Other Observable Inputs
(Level 2) |
|
Significant Unobservable Inputs
(Level 3) |
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Debt and equity securities held in rabbi trusts
|
$
|
33.1
|
|
|
$
|
22.4
|
|
|
$
|
10.7
|
|
|
$
|
—
|
|
Equity securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
$
|
33.1
|
|
|
$
|
22.4
|
|
|
$
|
10.7
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Deferred compensation liabilities
|
$
|
38.5
|
|
|
$
|
—
|
|
|
$
|
38.5
|
|
|
$
|
—
|
|
Contingent consideration and acquired contingent liabilities
|
151.4
|
|
|
—
|
|
|
—
|
|
|
151.4
|
|
||||
|
$
|
189.9
|
|
|
$
|
—
|
|
|
$
|
38.5
|
|
|
$
|
151.4
|
|
|
December 29,
2017 |
|
Quoted Prices in Active Markets for Identical Assets
(Level 1)
|
|
Significant Other Observable Inputs
(Level 2)
|
|
Significant Unobservable Inputs
(Level 3)
|
||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Debt and equity securities held in rabbi trusts
|
$
|
35.4
|
|
|
$
|
24.0
|
|
|
$
|
11.4
|
|
|
$
|
—
|
|
Equity securities
|
22.7
|
|
|
22.7
|
|
|
—
|
|
|
—
|
|
||||
|
$
|
58.1
|
|
|
$
|
46.7
|
|
|
$
|
11.4
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
Deferred compensation liabilities
|
$
|
42.7
|
|
|
$
|
—
|
|
|
$
|
42.7
|
|
|
$
|
—
|
|
Contingent consideration and acquired contingent liabilities
|
246.4
|
|
|
—
|
|
|
—
|
|
|
246.4
|
|
||||
|
$
|
289.1
|
|
|
$
|
—
|
|
|
$
|
42.7
|
|
|
$
|
246.4
|
|
Balance at December 29, 2017
|
$
|
246.4
|
|
Disposal of business
|
(12.1
|
)
|
|
Payments
|
(37.0
|
)
|
|
Accretion expense
|
4.3
|
|
|
Fair value adjustment
|
(50.2
|
)
|
|
Balance at December 28, 2018
|
$
|
151.4
|
|
•
|
The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and the majority of other current assets and liabilities approximate fair value because of their short-term nature. The Company classifies cash on hand and deposits in banks, including commercial paper, money market accounts and other investments it may hold from time to time, with an original maturity to the Company of three months or less, as cash and cash equivalents (level 1). The fair value of restricted cash is equivalent to its carrying value of $18.6 million and $18.3 million as of December 28, 2018 and December 29, 2017, respectively (level 1), substantially all of which is included in other assets on the consolidated balance sheets.
|
•
|
The Company received a portion of consideration for the sale of the Intrathecal business in the form of a note receivable. The fair value of the note receivable was equivalent to its carrying value of $154.0 million as of December 29, 2017 (level 1). During fiscal 2018, the Company received $154.0 million from Piramal for settlement of the aforementioned note receivable.
|
•
|
The Company received a portion of consideration as part of contingent earn-out payments related to the sale of the Nuclear Imaging business in the form of preferred equity certificates during fiscal 2018. These securities are classified as held-to-maturity and are carried at amortized cost, which approximates fair value, of $9.0 million at December 28, 2018 (level 3). These securities are included in other assets on the consolidated balance sheet.
|
•
|
The Company's life insurance contracts are carried at cash surrender value, which is based on the present value of future cash flows under the terms of the contracts (level 3). Significant assumptions used in determining the cash surrender value include the amount and timing of future cash flows, interest rates and mortality charges. The fair value of these contracts approximates the carrying value of $66.4 million and $67.0 million at December 28, 2018 and December 29, 2017, respectively. These contracts are included in other assets on the consolidated balance sheets.
|
•
|
The carrying values of the Company's revolving credit facility and variable-rate receivable securitization approximate the fair values due to the short-term nature of these instruments, and is therefore classified as level 1. The Company's 3.50%, 4.75%, 4.875%, 5.50%, 5.625% and 5.75% notes are classified as level 1, as quoted prices are available in an active market for these notes. Since the quoted market prices for the Company's term loans and 8.00% and 9.50% debentures are not available in an active market, they are classified as level 2 for purposes of developing an estimate of fair value. The fair value of the "other" loan is based on the present value of future cash flows under the terms of the agreement with future cash flows and interest rates as significant assumptions, and therefore classified as level 3. The following table presents the carrying values and estimated fair values of the Company's long-term debt, excluding capital leases, as of the end of each period:
|
|
|
December 28, 2018
|
|
December 29, 2017
|
||||||||||||
|
|
Carrying
Value
|
|
Fair
Value
|
|
Carrying
Value
|
|
Fair
Value
|
||||||||
Level 1:
|
|
|
|
|
|
|
|
|
||||||||
3.50% notes due April 2018
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
300.0
|
|
|
$
|
299.1
|
|
4.875% notes due April 2020
|
|
700.0
|
|
|
676.6
|
|
|
700.0
|
|
|
675.2
|
|
||||
Variable-rate receivable securitization due July 2020
|
|
250.0
|
|
|
250.0
|
|
|
200.0
|
|
|
200.0
|
|
||||
5.75% notes due August 2022
|
|
835.2
|
|
|
713.6
|
|
|
884.0
|
|
|
804.8
|
|
||||
4.75% notes due April 2023
|
|
500.2
|
|
|
336.7
|
|
|
526.5
|
|
|
412.4
|
|
||||
5.625% notes due October 2023
|
|
731.4
|
|
|
557.0
|
|
|
738.0
|
|
|
628.8
|
|
||||
5.50% notes due April 2025
|
|
692.1
|
|
|
479.1
|
|
|
692.1
|
|
|
564.5
|
|
||||
Revolving credit facility
|
|
220.0
|
|
|
220.0
|
|
|
900.0
|
|
|
900.0
|
|
||||
Level 2:
|
|
|
|
|
|
|
|
|
||||||||
9.50% debentures due May 2022
|
|
10.4
|
|
|
9.7
|
|
|
10.4
|
|
|
10.9
|
|
||||
8.00% debentures due March 2023
|
|
4.4
|
|
|
3.8
|
|
|
4.4
|
|
|
4.4
|
|
||||
Term loan due September 2024
|
|
1,613.8
|
|
|
1,472.4
|
|
|
1,851.2
|
|
|
1,848.7
|
|
||||
Term loan due February 2025
|
|
597.0
|
|
|
548.0
|
|
|
—
|
|
|
—
|
|
||||
Level 3:
|
|
|
|
|
|
|
|
|
||||||||
Other
|
|
2.2
|
|
|
2.2
|
|
|
—
|
|
|
—
|
|
||||
Total Debt
|
|
$
|
6,156.7
|
|
|
$
|
5,269.1
|
|
|
$
|
6,806.6
|
|
|
$
|
6,348.8
|
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||
|
December 28,
2018 |
|
December 29,
2017 |
|
September 30,
2016 |
|
December 30,
2016 |
||||
CuraScript, Inc.
|
35
|
%
|
|
40
|
%
|
|
38
|
%
|
|
43
|
%
|
McKesson Corporation
|
*
|
|
|
*
|
|
|
12
|
%
|
|
10
|
%
|
|
December 28,
2018 |
|
December 29,
2017 |
||
AmerisourceBergen Corporation
|
26
|
%
|
|
15
|
%
|
McKesson Corporation
|
22
|
%
|
|
26
|
%
|
CuraScript, Inc.
|
13
|
%
|
|
14
|
%
|
Cardinal Health, Inc.
|
*
|
|
|
11
|
%
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||
|
December 28,
2018 |
|
December 29,
2017 |
|
September 30,
2016 |
|
December 30,
2016 |
||||
H.P. Acthar Gel
|
35
|
%
|
|
37
|
%
|
|
34
|
%
|
|
39
|
%
|
Inomax
|
17
|
%
|
|
16
|
%
|
|
14
|
%
|
|
14
|
%
|
22.
|
Segment and Geographical Data
|
•
|
Specialty Brands includes innovative specialty pharmaceutical brands; and
|
•
|
Specialty Generics and Amitiza includes niche specialty generic drugs products, APIs and Amitiza.
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Net sales:
|
|
|
|
|
|
|
|
||||||||
Specialty Brands
|
$
|
2,306.2
|
|
|
$
|
2,352.0
|
|
|
$
|
2,288.8
|
|
|
$
|
600.1
|
|
Specialty Generics and Amitiza
|
909.4
|
|
|
869.6
|
|
|
1,092.0
|
|
|
229.8
|
|
||||
Net sales
|
$
|
3,215.6
|
|
|
$
|
3,221.6
|
|
|
$
|
3,380.8
|
|
|
$
|
829.9
|
|
Operating income:
|
|
|
|
|
|
|
|
||||||||
Specialty Brands
|
$
|
1,077.4
|
|
|
$
|
1,146.3
|
|
|
$
|
1,060.7
|
|
|
$
|
295.2
|
|
Specialty Generics and Amitiza
|
105.0
|
|
|
266.4
|
|
|
444.7
|
|
|
64.6
|
|
||||
Segment operating income
|
1,182.4
|
|
|
1,412.7
|
|
|
1,505.4
|
|
|
359.8
|
|
||||
Unallocated amounts:
|
|
|
|
|
|
|
|
||||||||
Corporate and allocated expenses (1)
|
(155.8
|
)
|
|
(125.2
|
)
|
|
(117.7
|
)
|
|
(123.1
|
)
|
||||
Intangible asset amortization
|
(740.2
|
)
|
|
(694.5
|
)
|
|
(700.1
|
)
|
|
(175.7
|
)
|
||||
Restructuring and related charges, net (2)
|
(108.2
|
)
|
|
(36.4
|
)
|
|
(37.6
|
)
|
|
(5.3
|
)
|
||||
Non-restructuring impairments
|
(3,893.1
|
)
|
|
(63.7
|
)
|
|
(16.9
|
)
|
|
(214.3
|
)
|
||||
Separation costs (3)
|
(6.0
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Operating income
|
$
|
(3,720.9
|
)
|
|
$
|
492.9
|
|
|
$
|
633.1
|
|
|
$
|
(158.6
|
)
|
|
|
|
|
|
|
|
|
||||||||
Depreciation and amortization (4):
|
|
|
|
|
|
|
|
||||||||
Specialty Brands
|
$
|
696.0
|
|
|
$
|
712.0
|
|
|
$
|
715.7
|
|
|
$
|
178.2
|
|
Specialty Generics and Amitiza
|
156.1
|
|
|
96.3
|
|
|
97.9
|
|
|
25.0
|
|
||||
|
$
|
852.1
|
|
|
$
|
808.3
|
|
|
$
|
813.6
|
|
|
$
|
203.2
|
|
(1)
|
Includes administration expenses and certain compensation, environmental and other costs not charged to the Company's operating segments.
|
(2)
|
Includes restructuring-related accelerated depreciation.
|
(3)
|
Represents costs incurred related to the separation of the Company’s Specialty Generics and Amitiza segment, which are included in selling, general and administrative expenses.
|
(4)
|
Depreciation for certain shared facilities is allocated based on occupancy percentage.
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
H.P. Acthar Gel
|
$
|
1,110.1
|
|
|
$
|
1,195.1
|
|
|
$
|
1,160.4
|
|
|
$
|
325.4
|
|
Inomax
|
542.7
|
|
|
505.2
|
|
|
474.3
|
|
|
118.3
|
|
||||
Ofirmev
|
341.9
|
|
|
302.5
|
|
|
284.3
|
|
|
72.5
|
|
||||
Therakos
|
231.2
|
|
|
214.9
|
|
|
207.6
|
|
|
47.4
|
|
||||
BioVectra
|
53.1
|
|
|
54.7
|
|
|
49.5
|
|
|
7.4
|
|
||||
Other (1)
|
27.2
|
|
|
79.6
|
|
|
112.7
|
|
|
29.1
|
|
||||
Specialty Brands
|
2,306.2
|
|
|
2,352.0
|
|
|
2,288.8
|
|
|
600.1
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Hydrocodone (API) and hydrocodone-containing tablets
|
65.9
|
|
|
85.3
|
|
|
146.5
|
|
|
23.2
|
|
||||
Oxycodone (API) and oxycodone-containing tablets (1)
|
66.1
|
|
|
88.0
|
|
|
139.9
|
|
|
27.2
|
|
||||
Acetaminophen (API) (1)
|
192.7
|
|
|
185.5
|
|
|
169.1
|
|
|
40.8
|
|
||||
Amitiza (2)
|
183.8
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Other controlled substances (1)
|
343.8
|
|
|
412.0
|
|
|
543.9
|
|
|
117.4
|
|
||||
Other (1), (3)
|
57.1
|
|
|
98.8
|
|
|
92.6
|
|
|
21.2
|
|
||||
Specialty Generics and Amitiza
|
909.4
|
|
|
869.6
|
|
|
1,092.0
|
|
|
229.8
|
|
||||
Net Sales
|
$
|
3,215.6
|
|
|
$
|
3,221.6
|
|
|
$
|
3,380.8
|
|
|
$
|
829.9
|
|
(1)
|
Prior year amounts have been reclassified to conform to current year presentation.
|
(2)
|
Amitiza net sales consist of both product and royalty net sales. Refer to Note 5 for further details on Amitiza's revenues.
|
(3)
|
Includes net sales from an ongoing, post-divestiture supply agreement with the acquirer of the CMDS business. Amounts for periods prior to the divestiture represent the reclassification of intercompany sales to third-party sales to conform with the expected presentation of the ongoing supply agreement.
|
|
Fiscal Year Ended
|
|
Three Months Ended
|
||||||||||||
|
December 28, 2018
|
|
December 29, 2017
|
|
September 30, 2016
|
|
December 30, 2016
|
||||||||
Net sales (1):
|
|
|
|
|
|
|
|
||||||||
U.S.
|
$
|
2,834.5
|
|
|
$
|
2,899.0
|
|
|
$
|
3,095.4
|
|
|
$
|
763.7
|
|
Europe, Middle East and Africa
|
256.8
|
|
|
242.3
|
|
|
211.8
|
|
|
52.8
|
|
||||
Other
|
124.3
|
|
|
80.3
|
|
|
73.6
|
|
|
13.4
|
|
||||
|
$
|
3,215.6
|
|
|
$
|
3,221.6
|
|
|
$
|
3,380.8
|
|
|
$
|
829.9
|
|
|
|
|
|
|
|
|
|
||||||||
|
Fiscal Year Ended
|
|
|
|
|
||||||||||
Long-lived assets (2):
|
December 28, 2018
|
|
December 29, 2017
|
|
|
|
|
||||||||
U.S.
|
$
|
770.7
|
|
|
$
|
788.5
|
|
|
|
|
|
||||
Europe, Middle East and Africa (3)
|
146.7
|
|
|
127.0
|
|
|
|
|
|
||||||
Other
|
76.8
|
|
|
63.5
|
|
|
|
|
|
||||||
|
$
|
994.2
|
|
|
$
|
979.0
|
|
|
|
|
|
(1)
|
Net sales are attributed to regions based on the location of the entity that records the transaction, none of which relate to the country of Ireland.
|
(2)
|
Long-lived assets are primarily composed of property, plant and equipment, net.
|
(3)
|
Includes long-lived assets located in Ireland of $145.2 million and $126.0 million as of December 28, 2018 and December 29, 2017, respectively.
|
23.
|
Selected Quarterly Financial Data (Unaudited)
|
|
For the Quarter Ended (1)
|
||||||||||||||
|
March 30,
2018 |
|
June 29,
2018 |
|
September 28,
2018 |
|
December 28,
2018 |
||||||||
Net sales
|
$
|
755.3
|
|
|
$
|
825.5
|
|
|
$
|
799.9
|
|
|
$
|
834.9
|
|
Gross profit (2)
|
347.5
|
|
|
394.0
|
|
|
366.4
|
|
|
363.3
|
|
||||
(Loss) income from continuing operations (3)
|
(20.9
|
)
|
|
3.2
|
|
|
114.2
|
|
|
(3,718.4
|
)
|
||||
Income (loss) from discontinued operations
|
2.9
|
|
|
12.4
|
|
|
(0.4
|
)
|
|
—
|
|
||||
Net (loss) income
|
(18.0
|
)
|
|
15.6
|
|
|
113.8
|
|
|
(3,718.4
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Basic (loss) earnings per share from continuing operations (4)
|
$
|
(0.24
|
)
|
|
$
|
0.04
|
|
|
$
|
1.37
|
|
|
$
|
(44.64
|
)
|
Diluted (loss) earnings per share from continuing operations (4)
|
(0.24
|
)
|
|
0.04
|
|
|
1.34
|
|
|
(44.64
|
)
|
||||
|
|||||||||||||||
|
For the Quarter Ended
|
||||||||||||||
|
March 31,
2017 |
|
June 30,
2017 |
|
September 29,
2017 |
|
December 29,
2017 |
||||||||
Net sales
|
$
|
810.9
|
|
|
$
|
824.5
|
|
|
$
|
793.9
|
|
|
$
|
792.3
|
|
Gross profit (2)
|
419.8
|
|
|
416.1
|
|
|
400.6
|
|
|
421.0
|
|
||||
Income from continuing operations (3)
|
28.9
|
|
|
70.6
|
|
|
64.3
|
|
|
1,607.4
|
|
||||
Income (loss) from discontinued operations
|
370.3
|
|
|
(7.8
|
)
|
|
(0.6
|
)
|
|
1.3
|
|
||||
Net income
|
399.2
|
|
|
62.8
|
|
|
63.7
|
|
|
1,608.7
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Basic earnings per share from continuing operations (4)
|
$
|
0.28
|
|
|
$
|
0.72
|
|
|
$
|
0.66
|
|
|
$
|
17.43
|
|
Diluted earnings per share from continuing operations (4)
|
0.28
|
|
|
0.72
|
|
|
0.66
|
|
|
17.40
|
|
(1)
|
The Specialty Generics Disposal Group was included within discontinued operations during the first three quarters of fiscal 2018, and has subsequently been recast to be included within continuing operations. In accordance with U.S. GAAP, depreciation and amortization are not recorded during the period in which a disposal group is classified as held-for-sale, thus the Company's financial results during the first three quarters of fiscal 2018 did not include $17.7 million and $6.8 million of depreciation and amortization expense, respectively, related to the Specialty Generics Disposal Group. During the fourth quarter of 2018, the Specialty Generics Disposal Group was reclassified to held and used and measured at its carrying amount before it was classified as held-for-sale, adjusted for depreciation and amortization expense that would have been recognized had the disposal group been continuously classified as held and used. The total adjustment of $24.5 million was reflected in loss from continuing operations during the fourth quarter of 2018, the period in which the held-for-sale criteria were no longer met.
|
(2)
|
Financial data for each period has been adjusted to reflect the change in accounting for pension and postretirement costs with the adoption of ASU 2017-07. See Note 4 for further information.
|
(3)
|
(Loss) income from continuing operations for the quarter ended December 28, 2018 reflects impairment charges for goodwill and an IPR&D asset. See Note 13 for further information. Income from continuing operations for the quarter ended December 29, 2017 reflects one-time effects for the completion of the reorganization of the Company's legal entity ownership and the impact of the TCJA.
|
(4)
|
Quarterly and annual computations are prepared independently. Therefore, the sum of each quarter may not necessarily total the fiscal period amounts noted elsewhere within this Annual Report on Form 10-K.
|
24.
|
Condensed Consolidating Financial Statements
|
|
Mallinckrodt plc
|
|
Mallinckrodt International Finance S.A.
|
|
Other Subsidiaries
|
|
Eliminations
|
|
Consolidated
|
||||||||||
Assets
|
|
|
|
|
|
|
|
|
|
||||||||||
Current Assets:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and cash equivalents
|
$
|
0.4
|
|
|
$
|
140.8
|
|
|
$
|
207.7
|
|
|
$
|
—
|
|
|
$
|
348.9
|
|
Accounts receivable, net
|
—
|
|
|
—
|
|
|
623.3
|
|
|
—
|
|
|
623.3
|
|
|||||
Inventories
|
—
|
|
|
—
|
|
|
322.3
|
|
|
—
|
|
|
322.3
|
|
|||||
Prepaid expenses and other current assets
|
3.9
|
|
|
0.2
|
|
|
128.6
|
|
|
—
|
|
|
132.7
|
|
|||||
Notes receivable
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Intercompany receivable
|
131.1
|
|
|
29.2
|
|
|
1,087.9
|
|
|
(1,248.2
|
)
|
|
—
|
|
|||||
Total current assets
|
135.4
|
|
|
170.2
|
|
|
2,369.8
|
|
|
(1,248.2
|
)
|
|
1,427.2
|
|
|||||
Property, plant and equipment, net
|
—
|
|
|
—
|
|
|
982.0
|
|
|
—
|
|
|
982.0
|
|
|||||
Goodwill
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Intangible assets, net
|
—
|
|
|
—
|
|
|
8,282.8
|
|
|
—
|
|
|
8,282.8
|
|
|||||
Investment in subsidiaries
|
2,481.6
|
|
|
25,506.1
|
|
|
8,362.1
|
|
|
(36,349.8
|
)
|
|
—
|
|
|||||
Intercompany loan receivable
|
497.7
|
|
|
—
|
|
|
12,343.0
|
|
|
(12,840.7
|
)
|
|
—
|
|
|||||
Other assets
|
—
|
|
|
—
|
|
|
185.3
|
|
|
—
|
|
|
185.3
|
|
|||||
Total Assets
|
$
|
3,114.7
|
|
|
$
|
25,676.3
|
|
|
$
|
32,525.0
|
|
|
$
|
(50,438.7
|
)
|
|
$
|
10,877.3
|
|
|
|
|
|
|
|
|
|
|
—
|
|
|||||||||
Liabilities and Shareholders' Equity
|
|
|
|
|
|
|
|
|
|
||||||||||
Current Liabilities:
|
|
|
|
|
|
|
|
|
|
||||||||||
Current maturities of long-term debt
|
$
|
—
|
|
|
$
|
22.1
|
|
|
$
|
0.3
|
|
|
$
|
—
|
|
|
$
|
22.4
|
|
Accounts payable
|
0.1
|
|
|
—
|
|
|
147.4
|
|
|
—
|
|
|
147.5
|
|
|||||
Accrued payroll and payroll-related costs
|
—
|
|
|
—
|
|
|
124.0
|
|
|
—
|
|
|
124.0
|
|
|||||
Accrued interest
|
—
|
|
|
48.7
|
|
|
28.9
|
|
|
—
|
|
|
77.6
|
|
|||||
Income taxes payable
|
—
|
|
|
—
|
|
|
25.0
|
|
|
—
|
|
|
25.0
|
|
|||||
Accrued and other current liabilities
|
0.6
|
|
|
0.4
|
|
|
546.2
|
|
|
—
|
|
|
547.2
|
|
|||||
Intercompany payable
|
226.7
|
|
|
827.8
|
|
|
193.7
|
|
|
(1,248.2
|
)
|
|
—
|
|
|||||
Total current liabilities
|
227.4
|
|
|
899.0
|
|
|
1,065.5
|
|
|
(1,248.2
|
)
|
|
943.7
|
|
|||||
Long-term debt
|
—
|
|
|
3,566.9
|
|
|
2,502.3
|
|
|
—
|
|
|
6,069.2
|
|
|||||
Pension and postretirement benefits
|
—
|
|
|
—
|
|
|
60.5
|
|
|
—
|
|
|
60.5
|
|
|||||
Environmental liabilities
|
—
|
|
|
—
|
|
|
59.7
|
|
|
—
|
|
|
59.7
|
|
|||||
Deferred income taxes
|
—
|
|
|
—
|
|
|
324.3
|
|
|
—
|
|
|
324.3
|
|
|||||
Other income tax liabilities
|
—
|
|
|
—
|
|
|
228.0
|
|
|
—
|
|
|
228.0
|
|
|||||
Intercompany loans payable
|
—
|
|
|
12,840.7
|
|
|
—
|
|
|
(12,840.7
|
)
|
|
—
|
|
|||||
Other liabilities
|
—
|
|
|
7.6
|
|
|
297.0
|
|
|
—
|
|
|
304.6
|
|
|||||
Total liabilities
|
227.4
|
|
|
17,314.2
|
|
|
4,537.3
|
|
|
(14,088.9
|
)
|
|
7,990.0
|
|
|||||
Shareholders' equity
|
2,887.3
|
|
|
8,362.1
|
|
|
27,987.7
|
|
|
(36,349.8
|
)
|
|
2,887.3
|
|
|||||
Total Liabilities and Shareholders' Equity
|
$
|
3,114.7
|
|
|
$
|
25,676.3
|
|
|
$
|
32,525.0
|
|
|
$
|
(50,438.7
|
)
|
|
$
|
10,877.3
|
|
|
Mallinckrodt plc
|
|
Mallinckrodt International Finance S.A.
|
|
Other Subsidiaries
|
|
Eliminations
|
|
Consolidated
|
||||||||||
Assets
|
|
|
|
|
|
|
|
|
|
||||||||||
Current Assets:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and cash equivalents
|
$
|
0.7
|
|
|
$
|
908.8
|
|
|
$
|
351.4
|
|
|
$
|
—
|
|
|
$
|
1,260.9
|
|
Accounts receivable, net
|
—
|
|
|
—
|
|
|
445.8
|
|
|
—
|
|
|
445.8
|
|
|||||
Inventories
|
—
|
|
|
—
|
|
|
340.4
|
|
|
—
|
|
|
340.4
|
|
|||||
Prepaid expenses and other current assets
|
1.0
|
|
|
0.2
|
|
|
82.9
|
|
|
—
|
|
|
84.1
|
|
|||||
Notes receivable
|
—
|
|
|
—
|
|
|
154.0
|
|
|
—
|
|
|
154.0
|
|
|||||
Intercompany receivable
|
70.0
|
|
|
173.4
|
|
|
831.4
|
|
|
(1,074.8
|
)
|
|
—
|
|
|||||
Total current assets
|
71.7
|
|
|
1,082.4
|
|
|
2,205.9
|
|
|
(1,074.8
|
)
|
|
2,285.2
|
|
|||||
Property, plant and equipment, net
|
—
|
|
|
—
|
|
|
966.8
|
|
|
—
|
|
|
966.8
|
|
|||||
Goodwill
|
—
|
|
|
—
|
|
|
3,482.7
|
|
|
—
|
|
|
3,482.7
|
|
|||||
Intangible assets, net
|
—
|
|
|
—
|
|
|
8,375.0
|
|
|
—
|
|
|
8,375.0
|
|
|||||
Investment in subsidiaries
|
6,551.6
|
|
|
23,217.8
|
|
|
12,356.2
|
|
|
(42,125.6
|
)
|
|
—
|
|
|||||
Intercompany loan receivable
|
593.1
|
|
|
—
|
|
|
4,664.8
|
|
|
(5,257.9
|
)
|
|
—
|
|
|||||
Other assets
|
—
|
|
|
—
|
|
|
171.2
|
|
|
—
|
|
|
171.2
|
|
|||||
Total Assets
|
$
|
7,216.4
|
|
|
$
|
24,300.2
|
|
|
$
|
32,222.6
|
|
|
$
|
(48,458.3
|
)
|
|
$
|
15,280.9
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Liabilities and Shareholders' Equity
|
|
|
|
|
|
|
|
|
|
||||||||||
Current Liabilities:
|
|
|
|
|
|
|
|
|
|
||||||||||
Current maturities of long-term debt
|
$
|
—
|
|
|
$
|
313.5
|
|
|
$
|
0.2
|
|
|
$
|
—
|
|
|
$
|
313.7
|
|
Accounts payable
|
0.1
|
|
|
—
|
|
|
113.2
|
|
|
—
|
|
|
113.3
|
|
|||||
Accrued payroll and payroll-related costs
|
—
|
|
|
—
|
|
|
98.5
|
|
|
—
|
|
|
98.5
|
|
|||||
Accrued interest
|
—
|
|
|
53.0
|
|
|
4.0
|
|
|
—
|
|
|
57.0
|
|
|||||
Income taxes payable
|
—
|
|
|
—
|
|
|
15.8
|
|
|
|
|
15.8
|
|
||||||
Accrued and other current liabilities
|
0.8
|
|
|
0.4
|
|
|
450.9
|
|
|
—
|
|
|
452.1
|
|
|||||
Intercompany payable
|
693.5
|
|
|
104.6
|
|
|
276.7
|
|
|
(1,074.8
|
)
|
|
—
|
|
|||||
Total current liabilities
|
694.4
|
|
|
471.5
|
|
|
959.3
|
|
|
(1,074.8
|
)
|
|
1,050.4
|
|
|||||
Long-term debt
|
—
|
|
|
6,206.8
|
|
|
214.1
|
|
|
—
|
|
|
6,420.9
|
|
|||||
Pension and postretirement benefits
|
—
|
|
|
—
|
|
|
67.1
|
|
|
—
|
|
|
67.1
|
|
|||||
Environmental liabilities
|
—
|
|
|
—
|
|
|
73.2
|
|
|
—
|
|
|
73.2
|
|
|||||
Deferred income taxes
|
—
|
|
|
—
|
|
|
689.0
|
|
|
—
|
|
|
689.0
|
|
|||||
Other income tax liabilities
|
—
|
|
|
—
|
|
|
94.1
|
|
|
—
|
|
|
94.1
|
|
|||||
Intercompany loans payable
|
—
|
|
|
5,257.9
|
|
|
—
|
|
|
(5,257.9
|
)
|
|
—
|
|
|||||
Other liabilities
|
—
|
|
|
7.8
|
|
|
356.4
|
|
|
—
|
|
|
364.2
|
|
|||||
Total liabilities
|
694.4
|
|
|
11,944.0
|
|
|
2,453.2
|
|
|
(6,332.7
|
)
|
|
8,758.9
|
|
|||||
Shareholders' equity
|
6,522.0
|
|
|
12,356.2
|
|
|
29,769.4
|
|
|
(42,125.6
|
)
|
|
6,522.0
|
|
|||||
Total Liabilities and Shareholders' Equity
|
$
|
7,216.4
|
|
|
$
|
24,300.2
|
|
|
$
|
32,222.6
|
|
|
$
|
(48,458.3
|
)
|
|
$
|
15,280.9
|
|
|
Mallinckrodt plc
|
|
Mallinckrodt International Finance S.A.
|
|
Other Subsidiaries
|
|
Eliminations
|
|
Consolidated
|
||||||||||
Net sales
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,215.6
|
|
|
$
|
—
|
|
|
$
|
3,215.6
|
|
Cost of sales
|
2.0
|
|
|
—
|
|
|
1,742.4
|
|
|
—
|
|
|
1,744.4
|
|
|||||
Gross (loss) profit
|
(2.0
|
)
|
|
—
|
|
|
1,473.2
|
|
|
—
|
|
|
1,471.2
|
|
|||||
Selling, general and administrative expenses
|
38.8
|
|
|
0.7
|
|
|
794.6
|
|
|
—
|
|
|
834.1
|
|
|||||
Research and development expenses
|
4.7
|
|
|
—
|
|
|
356.4
|
|
|
—
|
|
|
361.1
|
|
|||||
Restructuring charges, net
|
—
|
|
|
—
|
|
|
103.0
|
|
|
—
|
|
|
103.0
|
|
|||||
Non-restructuring impairment charges
|
—
|
|
|
—
|
|
|
3,893.1
|
|
|
—
|
|
|
3,893.1
|
|
|||||
Loss on divestiture
|
—
|
|
|
—
|
|
|
0.8
|
|
|
—
|
|
|
0.8
|
|
|||||
Operating loss
|
(45.5
|
)
|
|
(0.7
|
)
|
|
(3,674.7
|
)
|
|
—
|
|
|
(3,720.9
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest expense
|
(7.8
|
)
|
|
(460.8
|
)
|
|
(63.4
|
)
|
|
161.8
|
|
|
(370.2
|
)
|
|||||
Interest income
|
9.5
|
|
|
2.5
|
|
|
158.0
|
|
|
(161.8
|
)
|
|
8.2
|
|
|||||
Other income, net
|
9.9
|
|
|
8.7
|
|
|
12.3
|
|
|
—
|
|
|
30.9
|
|
|||||
Intercompany interest and fees
|
(18.5
|
)
|
|
(0.1
|
)
|
|
18.6
|
|
|
—
|
|
|
—
|
|
|||||
Equity in net income of subsidiaries
|
(3,561.0
|
)
|
|
(2,726.0
|
)
|
|
(3,170.9
|
)
|
|
9,457.9
|
|
|
—
|
|
|||||
Loss from continuing operations before income taxes
|
(3,613.4
|
)
|
|
(3,176.4
|
)
|
|
(6,720.1
|
)
|
|
9,457.9
|
|
|
(4,052.0
|
)
|
|||||
Benefit from income taxes
|
(6.4
|
)
|
|
(5.4
|
)
|
|
(418.3
|
)
|
|
—
|
|
|
(430.1
|
)
|
|||||
Loss from continuing operations
|
(3,607.0
|
)
|
|
(3,171.0
|
)
|
|
(6,301.8
|
)
|
|
9,457.9
|
|
|
(3,621.9
|
)
|
|||||
Income from discontinued operations, net of income taxes
|
—
|
|
|
0.1
|
|
|
14.8
|
|
|
—
|
|
|
14.9
|
|
|||||
Net loss
|
(3,607.0
|
)
|
|
(3,170.9
|
)
|
|
(6,287.0
|
)
|
|
9,457.9
|
|
|
(3,607.0
|
)
|
|||||
Other comprehensive loss, net of tax
|
(9.9
|
)
|
|
(9.9
|
)
|
|
(20.5
|
)
|
|
30.4
|
|
|
(9.9
|
)
|
|||||
Comprehensive loss
|
$
|
(3,616.9
|
)
|
|
$
|
(3,180.8
|
)
|
|
$
|
(6,307.5
|
)
|
|
$
|
9,488.3
|
|
|
$
|
(3,616.9
|
)
|
|
Mallinckrodt plc
|
|
Mallinckrodt International Finance S.A.
|
|
Other Subsidiaries
|
|
Eliminations
|
|
Consolidated
|
||||||||||
Net sales
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,221.6
|
|
|
$
|
—
|
|
|
$
|
3,221.6
|
|
Cost of sales
|
2.6
|
|
|
—
|
|
|
1,561.5
|
|
|
—
|
|
|
1,564.1
|
|
|||||
Gross (loss) profit
|
(2.6
|
)
|
|
—
|
|
|
1,660.1
|
|
|
—
|
|
|
1,657.5
|
|
|||||
Selling, general and administrative expenses
|
59.5
|
|
|
0.7
|
|
|
789.5
|
|
|
—
|
|
|
849.7
|
|
|||||
Research and development expenses
|
5.1
|
|
|
—
|
|
|
271.8
|
|
|
—
|
|
|
276.9
|
|
|||||
Restructuring charges, net
|
—
|
|
|
—
|
|
|
31.2
|
|
|
—
|
|
|
31.2
|
|
|||||
Non-restructuring impairments
|
—
|
|
|
—
|
|
|
63.7
|
|
|
—
|
|
|
63.7
|
|
|||||
Gains on divestiture
|
—
|
|
|
—
|
|
|
(56.9
|
)
|
|
—
|
|
|
(56.9
|
)
|
|||||
Operating (loss) income
|
(67.2
|
)
|
|
(0.7
|
)
|
|
560.8
|
|
|
—
|
|
|
492.9
|
|
|||||
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest expense
|
(13.8
|
)
|
|
(353.9
|
)
|
|
(74.2
|
)
|
|
72.8
|
|
|
(369.1
|
)
|
|||||
Interest income
|
7.3
|
|
|
1.2
|
|
|
68.9
|
|
|
(72.8
|
)
|
|
4.6
|
|
|||||
Other income (expense), net
|
20.3
|
|
|
(1.7
|
)
|
|
(85.4
|
)
|
|
—
|
|
|
(66.8
|
)
|
|||||
Intercompany interest and fees
|
(18.3
|
)
|
|
—
|
|
|
18.3
|
|
|
—
|
|
|
—
|
|
|||||
Equity in net income of subsidiaries
|
2,200.0
|
|
|
2,901.8
|
|
|
2,549.9
|
|
|
(7,651.7
|
)
|
|
—
|
|
|||||
Income from continuing operations before income taxes
|
2,128.3
|
|
|
2,546.7
|
|
|
3,038.3
|
|
|
(7,651.7
|
)
|
|
61.6
|
|
|||||
Benefit from income taxes
|
(6.1
|
)
|
|
(5.3
|
)
|
|
(1,698.2
|
)
|
|
—
|
|
|
(1,709.6
|
)
|
|||||
Income from continuing operations
|
2,134.4
|
|
|
2,552.0
|
|
|
4,736.5
|
|
|
(7,651.7
|
)
|
|
1,771.2
|
|
|||||
(Loss) income from discontinued operations, net of income taxes
|
—
|
|
|
(2.1
|
)
|
|
365.3
|
|
|
—
|
|
|
363.2
|
|
|||||
Net income
|
2,134.4
|
|
|
2,549.9
|
|
|
5,101.8
|
|
|
(7,651.7
|
)
|
|
2,134.4
|
|
|||||
Other comprehensive income, net of tax
|
59.6
|
|
|
59.6
|
|
|
118.2
|
|
|
(177.8
|
)
|
|
59.6
|
|
|||||
Comprehensive income
|
$
|
2,194.0
|
|
|
$
|
2,609.5
|
|
|
$
|
5,220.0
|
|
|
$
|
(7,829.5
|
)
|
|
$
|
2,194.0
|
|
|
Mallinckrodt plc
|
|
Mallinckrodt International Finance S.A.
|
|
Other Subsidiaries
|
|
Eliminations
|
|
Consolidated
|
||||||||||
Net sales
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3,380.8
|
|
|
$
|
—
|
|
|
$
|
3,380.8
|
|
Cost of sales
|
—
|
|
|
—
|
|
|
1,523.2
|
|
|
—
|
|
|
1,523.2
|
|
|||||
Gross profit
|
—
|
|
|
—
|
|
|
1,857.6
|
|
|
—
|
|
|
1,857.6
|
|
|||||
Selling, general and administrative expenses
|
51.3
|
|
|
0.8
|
|
|
861.6
|
|
|
—
|
|
|
913.7
|
|
|||||
Research and development expenses
|
—
|
|
|
—
|
|
|
261.2
|
|
|
—
|
|
|
261.2
|
|
|||||
Restructuring charges, net
|
—
|
|
|
—
|
|
|
32.7
|
|
|
—
|
|
|
32.7
|
|
|||||
Non-restructuring impairments
|
—
|
|
|
—
|
|
|
16.9
|
|
|
—
|
|
|
16.9
|
|
|||||
Operating (loss) income
|
(51.3
|
)
|
|
(0.8
|
)
|
|
685.2
|
|
|
—
|
|
|
633.1
|
|
|||||
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest expense
|
(230.3
|
)
|
|
(327.0
|
)
|
|
(82.4
|
)
|
|
255.1
|
|
|
(384.6
|
)
|
|||||
Interest income
|
—
|
|
|
0.5
|
|
|
255.9
|
|
|
(255.1
|
)
|
|
1.3
|
|
|||||
Other income (expense), net
|
90.0
|
|
|
1.7
|
|
|
(108.1
|
)
|
|
—
|
|
|
(16.4
|
)
|
|||||
Intercompany interest and fees
|
(16.1
|
)
|
|
—
|
|
|
16.1
|
|
|
—
|
|
|
—
|
|
|||||
Equity in net income of subsidiaries
|
820.8
|
|
|
1,327.2
|
|
|
1,057.9
|
|
|
(3,205.9
|
)
|
|
—
|
|
|||||
Income from continuing operations before income taxes
|
613.1
|
|
|
1,001.6
|
|
|
1,824.6
|
|
|
(3,205.9
|
)
|
|
233.4
|
|
|||||
Benefit from income taxes
|
(30.6
|
)
|
|
(18.1
|
)
|
|
(206.9
|
)
|
|
—
|
|
|
(255.6
|
)
|
|||||
Income from continuing operations
|
643.7
|
|
|
1,019.7
|
|
|
2,031.5
|
|
|
(3,205.9
|
)
|
|
489.0
|
|
|||||
Income from discontinued operations, net of income taxes
|
—
|
|
|
38.2
|
|
|
116.5
|
|
|
—
|
|
|
154.7
|
|
|||||
Net income
|
643.7
|
|
|
1,057.9
|
|
|
2,148.0
|
|
|
(3,205.9
|
)
|
|
643.7
|
|
|||||
Other comprehensive loss, net of tax
|
(86.5
|
)
|
|
(86.5
|
)
|
|
(173.5
|
)
|
|
260.0
|
|
|
(86.5
|
)
|
|||||
Comprehensive income
|
$
|
557.2
|
|
|
$
|
971.4
|
|
|
$
|
1,974.5
|
|
|
$
|
(2,945.9
|
)
|
|
$
|
557.2
|
|
|
Mallinckrodt plc
|
|
Mallinckrodt International Finance S.A.
|
|
Other Subsidiaries
|
|
Eliminations
|
|
Consolidated
|
||||||||||
Net sales
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
829.9
|
|
|
$
|
—
|
|
|
$
|
829.9
|
|
Cost of sales
|
—
|
|
|
—
|
|
|
383.2
|
|
|
—
|
|
|
383.2
|
|
|||||
Gross profit
|
—
|
|
|
—
|
|
|
446.7
|
|
|
—
|
|
|
446.7
|
|
|||||
Selling, general and administrative expenses
|
13.4
|
|
|
0.2
|
|
|
307.5
|
|
|
—
|
|
|
321.1
|
|
|||||
Research and development expenses
|
—
|
|
|
—
|
|
|
66.1
|
|
|
—
|
|
|
66.1
|
|
|||||
Restructuring charges, net
|
—
|
|
|
—
|
|
|
3.8
|
|
|
—
|
|
|
3.8
|
|
|||||
Non-restructuring impairments
|
—
|
|
|
—
|
|
|
214.3
|
|
|
—
|
|
|
214.3
|
|
|||||
Operating loss
|
(13.4
|
)
|
|
(0.2
|
)
|
|
(145.0
|
)
|
|
—
|
|
|
(158.6
|
)
|
|||||
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest expense
|
(2.9
|
)
|
|
(81.1
|
)
|
|
(17.9
|
)
|
|
10.6
|
|
|
(91.3
|
)
|
|||||
Interest income
|
—
|
|
|
0.1
|
|
|
11.0
|
|
|
(10.6
|
)
|
|
0.5
|
|
|||||
Other income (expense), net
|
1.8
|
|
|
0.7
|
|
|
(51.6
|
)
|
|
—
|
|
|
(49.1
|
)
|
|||||
Intercompany interest and fees
|
(4.4
|
)
|
|
—
|
|
|
4.4
|
|
|
—
|
|
|
—
|
|
|||||
Equity in net income of subsidiaries
|
(136.5
|
)
|
|
35.2
|
|
|
(44.5
|
)
|
|
145.8
|
|
|
—
|
|
|||||
Loss from continuing operations before income taxes
|
(155.4
|
)
|
|
(45.3
|
)
|
|
(243.6
|
)
|
|
145.8
|
|
|
(298.5
|
)
|
|||||
Benefit from income taxes
|
(2.2
|
)
|
|
(0.3
|
)
|
|
(119.2
|
)
|
|
—
|
|
|
(121.7
|
)
|
|||||
Loss from continuing operations
|
(153.2
|
)
|
|
(45.0
|
)
|
|
(124.4
|
)
|
|
145.8
|
|
|
(176.8
|
)
|
|||||
Income from discontinued operations, net of income taxes
|
—
|
|
|
0.4
|
|
|
23.2
|
|
|
—
|
|
|
23.6
|
|
|||||
Net loss
|
(153.2
|
)
|
|
(44.6
|
)
|
|
(101.2
|
)
|
|
145.8
|
|
|
(153.2
|
)
|
|||||
Other comprehensive income, net of tax
|
13.1
|
|
|
13.1
|
|
|
26.0
|
|
|
(39.1
|
)
|
|
13.1
|
|
|||||
Comprehensive loss
|
$
|
(140.1
|
)
|
|
$
|
(31.5
|
)
|
|
$
|
(75.2
|
)
|
|
$
|
106.7
|
|
|
$
|
(140.1
|
)
|
|
Mallinckrodt plc
|
|
Mallinckrodt International Finance S.A.
|
|
Other Subsidiaries
|
|
Eliminations
|
|
Consolidated
|
||||||||||
Cash Flows From Operating Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||
Net cash from operating activities
|
$
|
438.9
|
|
|
$
|
80.1
|
|
|
$
|
1,702.5
|
|
|
$
|
(1,556.0
|
)
|
|
$
|
665.5
|
|
Cash Flows From Investing Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||
Capital expenditures
|
—
|
|
|
—
|
|
|
(127.0
|
)
|
|
—
|
|
|
(127.0
|
)
|
|||||
Acquisitions, net of cash acquired
|
—
|
|
|
—
|
|
|
(699.9
|
)
|
|
—
|
|
|
(699.9
|
)
|
|||||
Proceeds from disposal of discontinued operations, net of cash
|
—
|
|
|
—
|
|
|
313.0
|
|
|
—
|
|
|
313.0
|
|
|||||
Intercompany loan investment
|
(385.6
|
)
|
|
(90.1
|
)
|
|
(502.0
|
)
|
|
977.7
|
|
|
—
|
|
|||||
Investment in subsidiary
|
—
|
|
|
(220.0
|
)
|
|
—
|
|
|
220.0
|
|
|
—
|
|
|||||
Proceeds from sale of subsidiary
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Acquisition of subsidiary
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Other
|
—
|
|
|
—
|
|
|
33.6
|
|
|
—
|
|
|
33.6
|
|
|||||
Net cash from investing activities
|
(385.6
|
)
|
|
(310.1
|
)
|
|
(982.3
|
)
|
|
1,197.7
|
|
|
(480.3
|
)
|
|||||
Cash Flows From Financing Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||
Issuance of external debt
|
—
|
|
|
600.0
|
|
|
90.3
|
|
|
—
|
|
|
690.3
|
|
|||||
Repayment of external debt and capital leases
|
—
|
|
|
(1,289.4
|
)
|
|
(404.2
|
)
|
|
—
|
|
|
(1,693.6
|
)
|
|||||
Debt financing costs
|
—
|
|
|
(12.1
|
)
|
|
—
|
|
|
—
|
|
|
(12.1
|
)
|
|||||
Proceeds from exercise of share options
|
1.0
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1.0
|
|
|||||
Intercompany loan borrowings
|
—
|
|
|
977.7
|
|
|
—
|
|
|
(977.7
|
)
|
|
—
|
|
|||||
Intercompany dividends
|
—
|
|
|
(814.2
|
)
|
|
(741.8
|
)
|
|
1,556.0
|
|
|
—
|
|
|||||
Capital contribution
|
—
|
|
|
—
|
|
|
220.0
|
|
|
(220.0
|
)
|
|
—
|
|
|||||
Repurchase of shares
|
(57.5
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(57.5
|
)
|
|||||
Other
|
2.9
|
|
|
—
|
|
|
(26.0
|
)
|
|
—
|
|
|
(23.1
|
)
|
|||||
Net cash from financing activities
|
(53.6
|
)
|
|
(538.0
|
)
|
|
(861.7
|
)
|
|
358.3
|
|
|
(1,095.0
|
)
|
|||||
Effect of currency rate changes on cash
|
—
|
|
|
—
|
|
|
(1.8
|
)
|
|
—
|
|
|
(1.8
|
)
|
|||||
Net decrease in cash, cash equivalents and restricted cash
|
(0.3
|
)
|
|
(768.0
|
)
|
|
(143.3
|
)
|
|
—
|
|
|
(911.6
|
)
|
|||||
Cash, cash equivalents and restricted cash at beginning of period
|
0.7
|
|
|
908.8
|
|
|
369.6
|
|
|
—
|
|
|
1,279.1
|
|
|||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
0.4
|
|
|
$
|
140.8
|
|
|
$
|
226.3
|
|
|
$
|
—
|
|
|
$
|
367.5
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash and cash equivalents at end of period
|
$
|
0.4
|
|
|
$
|
140.8
|
|
|
$
|
207.7
|
|
|
$
|
—
|
|
|
$
|
348.9
|
|
Restricted cash included in prepaid expenses and other assets at end of period
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Restricted cash included in other long-term assets at end of period
|
—
|
|
|
—
|
|
|
18.6
|
|
|
—
|
|
|
18.6
|
|
|||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
0.4
|
|
|
$
|
140.8
|
|
|
$
|
226.3
|
|
|
$
|
—
|
|
|
$
|
367.5
|
|
|
Mallinckrodt plc
|
|
Mallinckrodt International Finance S.A.
|
|
Other Subsidiaries
|
|
Eliminations
|
|
Consolidated
|
||||||||||||
Cash Flows From Operating Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||||
Net cash from operating activities
|
$
|
1,233.2
|
|
|
$
|
1,139.4
|
|
|
$
|
2,274.9
|
|
|
$
|
(3,920.2
|
)
|
|
$
|
727.3
|
|
||
Cash Flows From Investing Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||||
Capital expenditures
|
—
|
|
|
—
|
|
|
(186.1
|
)
|
|
—
|
|
|
(186.1
|
)
|
|||||||
Acquisitions, net of cash acquired
|
—
|
|
|
—
|
|
|
(76.3
|
)
|
|
—
|
|
|
(76.3
|
)
|
|||||||
Proceeds from disposal of discontinued operations, net of cash
|
—
|
|
|
—
|
|
|
576.9
|
|
|
—
|
|
|
576.9
|
|
|||||||
Intercompany loan investment
|
(589.5
|
)
|
|
—
|
|
|
(1,157.9
|
)
|
|
1,747.4
|
|
|
—
|
|
|||||||
Investment in subsidiary
|
—
|
|
|
(1,475.3
|
)
|
|
—
|
|
|
1,475.3
|
|
|
—
|
|
|||||||
Other
|
—
|
|
|
—
|
|
|
3.9
|
|
|
—
|
|
|
3.9
|
|
|||||||
Net cash from investing activities
|
(589.5
|
)
|
|
(1,475.3
|
)
|
|
(839.5
|
)
|
—
|
|
3,222.7
|
|
|
318.4
|
|
||||||
Cash Flows From Financing Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||||
Issuance of external debt
|
—
|
|
|
1,400.0
|
|
|
65.0
|
|
|
—
|
|
|
1,465.0
|
|
|||||||
Repayment of external debt and capital leases
|
—
|
|
|
(764.5
|
)
|
|
(152.7
|
)
|
|
—
|
|
|
(917.2
|
)
|
|||||||
Debt financing costs
|
—
|
|
|
(12.7
|
)
|
|
—
|
|
|
—
|
|
|
(12.7
|
)
|
|||||||
Proceeds from exercise of share options
|
4.1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4.1
|
|
|||||||
Intercompany loan borrowings
|
—
|
|
|
1,747.4
|
|
|
—
|
|
|
(1,747.4
|
)
|
|
—
|
|
|||||||
Intercompany dividends
|
—
|
|
|
(1,170.0
|
)
|
|
(2,750.2
|
)
|
|
3,920.2
|
|
|
—
|
|
|||||||
Capital contribution
|
—
|
|
|
—
|
|
|
1,475.3
|
|
|
(1,475.3
|
)
|
|
—
|
|
|||||||
Repurchase of shares
|
(651.7
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(651.7
|
)
|
|||||||
Other
|
4.1
|
|
|
—
|
|
|
(21.8
|
)
|
|
—
|
|
|
(17.7
|
)
|
|||||||
Net cash from financing activities
|
(643.5
|
)
|
|
1,200.2
|
|
—
|
|
(1,384.4
|
)
|
|
697.5
|
|
|
(130.2
|
)
|
||||||
Effect of currency rate changes on cash
|
—
|
|
|
—
|
|
|
2.5
|
|
|
—
|
|
|
2.5
|
|
|||||||
Net increase in cash, cash equivalents and restricted cash
|
0.2
|
|
|
864.3
|
|
|
53.5
|
|
|
—
|
|
|
918.0
|
|
|||||||
Cash, cash equivalents and restricted cash at beginning of period
|
0.5
|
|
|
44.5
|
|
|
316.1
|
|
|
—
|
|
|
361.1
|
|
|||||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
0.7
|
|
|
$
|
908.8
|
|
|
$
|
369.6
|
|
|
$
|
—
|
|
|
$
|
1,279.1
|
|
||
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cash and cash equivalents at end of period
|
$
|
0.7
|
|
|
$
|
908.8
|
|
|
$
|
351.4
|
|
|
$
|
—
|
|
|
$
|
1,260.9
|
|
||
Restricted cash included in prepaid expenses and other assets at end of period
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Restricted cash included in other long-term assets at end of period
|
—
|
|
|
—
|
|
|
18.2
|
|
|
—
|
|
|
18.2
|
|
|||||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
0.7
|
|
|
$
|
908.8
|
|
|
$
|
369.6
|
|
|
$
|
—
|
|
|
$
|
1,279.1
|
|
|
Mallinckrodt plc
|
|
Mallinckrodt International Finance S.A.
|
|
Other Subsidiaries
|
|
Eliminations
|
|
Consolidated
|
||||||||||||
Cash Flows From Operating Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||||
Net cash from operating activities
|
$
|
17.9
|
|
|
$
|
(47.4
|
)
|
|
$
|
1,214.1
|
|
|
$
|
—
|
|
|
$
|
1,184.6
|
|
||
Cash Flows From Investing Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||||
Capital expenditures
|
—
|
|
|
—
|
|
|
(182.9
|
)
|
|
—
|
|
|
(182.9
|
)
|
|||||||
Acquisitions, net of cash acquired
|
—
|
|
|
—
|
|
|
(245.4
|
)
|
|
—
|
|
|
(245.4
|
)
|
|||||||
Proceeds from disposal of discontinued operations, net of cash
|
—
|
|
|
234.0
|
|
|
32.7
|
|
|
—
|
|
|
266.7
|
|
|||||||
Intercompany loan investment
|
—
|
|
|
(175.2
|
)
|
|
(1,714.5
|
)
|
|
1,889.7
|
|
|
—
|
|
|||||||
Investment in subsidiary
|
—
|
|
|
(861.2
|
)
|
|
—
|
|
|
861.2
|
|
|
—
|
|
|||||||
Proceeds from sale of subsidiary
|
3.4
|
|
|
—
|
|
|
—
|
|
|
(3.4
|
)
|
|
—
|
|
|||||||
Acquisition of subsidiary
|
—
|
|
|
—
|
|
|
(3.4
|
)
|
|
3.4
|
|
|
—
|
|
|||||||
Other
|
—
|
|
|
—
|
|
|
6.0
|
|
|
—
|
|
|
6.0
|
|
|||||||
Net cash from investing activities
|
3.4
|
|
|
(802.4
|
)
|
|
(2,107.5
|
)
|
—
|
|
2,750.9
|
|
|
(155.6
|
)
|
||||||
Cash Flows From Financing Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||||
Issuance of external debt
|
—
|
|
|
—
|
|
|
98.3
|
|
|
—
|
|
|
98.3
|
|
|||||||
Repayment of external debt and capital leases
|
—
|
|
|
(549.2
|
)
|
|
(19.4
|
)
|
|
—
|
|
|
(568.6
|
)
|
|||||||
Debt financing costs
|
—
|
|
|
—
|
|
|
(0.1
|
)
|
|
—
|
|
|
(0.1
|
)
|
|||||||
Proceeds from exercise of share options
|
14.0
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14.0
|
|
|||||||
Intercompany loan borrowings
|
617.8
|
|
|
1,271.9
|
|
|
—
|
|
|
(1,889.7
|
)
|
|
—
|
|
|||||||
Capital contribution
|
—
|
|
|
—
|
|
|
861.2
|
|
|
(861.2
|
)
|
|
—
|
|
|||||||
Repurchase of shares
|
(652.9
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(652.9
|
)
|
|||||||
Other
|
—
|
|
|
—
|
|
|
(53.0
|
)
|
|
—
|
|
|
(53.0
|
)
|
|||||||
Net cash from financing activities
|
(21.1
|
)
|
|
722.7
|
|
—
|
|
887.0
|
|
|
(2,750.9
|
)
|
|
(1,162.3
|
)
|
||||||
Effect of currency rate changes on cash
|
—
|
|
|
—
|
|
|
0.3
|
|
|
—
|
|
|
0.3
|
|
|||||||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
0.2
|
|
|
(127.1
|
)
|
|
(6.1
|
)
|
|
—
|
|
|
(133.0
|
)
|
|||||||
Cash, cash equivalents and restricted cash at beginning of period
|
0.1
|
|
|
152.1
|
|
|
280.4
|
|
|
—
|
|
|
432.6
|
|
|||||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
0.3
|
|
|
$
|
25.0
|
|
|
$
|
274.3
|
|
|
$
|
—
|
|
|
$
|
299.6
|
|
||
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cash and cash equivalents at end of period
|
$
|
0.3
|
|
|
$
|
25.0
|
|
|
$
|
255.2
|
|
|
$
|
—
|
|
|
$
|
280.5
|
|
||
Restricted cash included in prepaid expenses and other assets at end of period
|
—
|
|
|
—
|
|
|
0.1
|
|
|
—
|
|
|
0.1
|
|
|||||||
Restricted cash included in other long-term assets at end of period
|
—
|
|
|
—
|
|
|
19.0
|
|
|
—
|
|
|
19.0
|
|
|||||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
0.3
|
|
|
$
|
25.0
|
|
|
$
|
274.3
|
|
|
$
|
—
|
|
|
$
|
299.6
|
|
|
Mallinckrodt plc
|
|
Mallinckrodt International Finance S.A.
|
|
Other Subsidiaries
|
|
Eliminations
|
|
Consolidated
|
||||||||||||
Cash Flows From Operating Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||||
Net cash from operating activities
|
$
|
17.4
|
|
|
$
|
(94.0
|
)
|
|
$
|
272.2
|
|
|
$
|
—
|
|
|
$
|
195.6
|
|
||
Cash Flows From Investing Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||||
Capital expenditures
|
—
|
|
|
—
|
|
|
(65.2
|
)
|
|
—
|
|
|
(65.2
|
)
|
|||||||
Acquisitions, net of cash acquired
|
—
|
|
|
—
|
|
|
(1.8
|
)
|
|
—
|
|
|
(1.8
|
)
|
|||||||
Intercompany loan investment
|
—
|
|
|
—
|
|
|
(424.7
|
)
|
|
424.7
|
|
|
—
|
|
|||||||
Subsidiary dividend proceeds
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Investment in subsidiary
|
—
|
|
|
(260.0
|
)
|
|
—
|
|
|
260.0
|
|
|
—
|
|
|||||||
Other
|
—
|
|
|
—
|
|
|
(10.2
|
)
|
|
—
|
|
|
(10.2
|
)
|
|||||||
Net cash from activities
|
—
|
|
|
(260.0
|
)
|
|
(501.9
|
)
|
—
|
|
684.7
|
|
|
(77.2
|
)
|
||||||
Cash Flows From Financing Activities:
|
|
|
|
|
|
|
|
|
|
||||||||||||
Issuance of external debt
|
—
|
|
|
175.0
|
|
|
15.0
|
|
|
—
|
|
|
190.0
|
|
|||||||
Repayment of external debt and capital leases
|
—
|
|
|
(86.2
|
)
|
|
(0.5
|
)
|
|
—
|
|
|
(86.7
|
)
|
|||||||
Debt financing costs
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Proceeds from exercise of share options
|
0.4
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
0.4
|
|
|||||||
Subsidiary dividend payment
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
Intercompany loan borrowings
|
140.0
|
|
|
284.7
|
|
|
—
|
|
|
(424.7
|
)
|
|
—
|
|
|||||||
Capital contribution
|
—
|
|
|
—
|
|
|
260.0
|
|
|
(260.0
|
)
|
|
—
|
|
|||||||
Repurchase of shares
|
(158.8
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(158.8
|
)
|
|||||||
Other
|
1.2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1.2
|
|
|||||||
Net cash from financing activities
|
(17.2
|
)
|
|
373.5
|
|
—
|
|
274.5
|
|
|
(684.7
|
)
|
|
(53.9
|
)
|
||||||
Effect of currency rate changes on cash
|
—
|
|
|
—
|
|
|
(3.0
|
)
|
|
—
|
|
|
(3.0
|
)
|
|||||||
Net increase in cash, cash equivalents and restricted cash
|
0.2
|
|
|
19.5
|
|
|
41.8
|
|
|
—
|
|
|
61.5
|
|
|||||||
Cash, cash equivalents and restricted cash at beginning of period
|
0.3
|
|
|
25.0
|
|
|
274.3
|
|
|
—
|
|
|
299.6
|
|
|||||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
0.5
|
|
|
$
|
44.5
|
|
|
$
|
316.1
|
|
|
$
|
—
|
|
|
$
|
361.1
|
|
||
|
|
|
|
|
|
|
|
|
|
||||||||||||
Cash and cash equivalents at end of period
|
$
|
0.5
|
|
|
$
|
44.5
|
|
|
$
|
297.0
|
|
|
$
|
—
|
|
|
$
|
342.0
|
|
||
Restricted cash included in prepaid expenses and other assets at end of period
|
—
|
|
|
—
|
|
|
0.1
|
|
|
—
|
|
|
0.1
|
|
|||||||
Restricted cash included in other long-term assets at end of period
|
—
|
|
|
—
|
|
|
19.0
|
|
|
—
|
|
|
19.0
|
|
|||||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
0.5
|
|
|
$
|
44.5
|
|
|
$
|
316.1
|
|
|
$
|
—
|
|
|
$
|
361.1
|
|
25.
|
Subsequent Events
|
Item 9.
|
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.
|
Item 9A.
|
Controls and Procedures.
|
•
|
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the Company’s assets;
|
•
|
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that the Company’s receipts and expenditures are being made only in accordance with authorizations of the Company’s management and directors; and
|
•
|
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect on the financial statements.
|
Item 9B.
|
Other Information.
|
Item 10.
|
Directors, Executive Officers and Corporate Governance.
|
Item 11.
|
Executive Compensation.
|
Item 12.
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
|
Item 13.
|
Certain Relationships and Related Transactions, and Director Independence.
|
Item 14.
|
Principal Accounting Fees and Services.
|
Item 15.
|
Exhibits, Financial Statement Schedules.
|
1)
|
Financial Statements. The following are included within Item 8. Financial Statements and Supplementary Data of this Annual Report on Form 10-K.
|
•
|
Report of Independent Registered Public Accounting Firm
|
•
|
Consolidated Statements of Income for the fiscal year ended December 28, 2018, December 29, 2017 and September 30, 2016 and the three months ended December 30, 2016
|
•
|
Consolidated Statements of Comprehensive Income for the fiscal year ended December 28, 2018, December 29, 2017 and September 30, 2016 and the three months ended December 30, 2016
|
•
|
Consolidated Balance Sheets as of December 28, 2018 and December 29, 2017
|
•
|
Consolidated Statements of Cash Flows for the fiscal year ended December 28, 2018, December 29, 2017 and September 30, 2016 and the three months ended December 30, 2016
|
•
|
Consolidated Statements of Changes in Shareholders' Equity for the period from September 25, 2015 to December 28, 2018
|
•
|
Notes to Consolidated Financial Statements
|
2)
|
Financial Statement Schedules. The financial statement schedule is included below. All other schedules have been omitted because they are not applicable, not required or the information is included in the financial statements or notes thereto.
|
Schedule II - Valuation and Qualifying Accounts
|
|
|
|
|
|
|
|
|
|
|
||||||||||
(in millions)
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Description
|
|
Balance at Beginning of Period
|
|
Charged to Income
|
|
Additions and Other
|
|
Deductions
|
|
Balance at End of Period
|
||||||||||
Allowance for doubtful accounts:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Fiscal year ended December 28, 2018
|
|
$
|
3.9
|
|
|
$
|
3.8
|
|
|
$
|
—
|
|
|
$
|
(2.7
|
)
|
|
$
|
5.0
|
|
Fiscal year ended December 29, 2017
|
|
4.0
|
|
|
0.6
|
|
|
—
|
|
|
(0.7
|
)
|
|
3.9
|
|
|||||
Three months ended December 30, 2016
|
|
4.0
|
|
|
0.1
|
|
|
—
|
|
|
(0.1
|
)
|
|
4.0
|
|
|||||
Fiscal year ended September 30, 2016
|
|
3.6
|
|
|
0.3
|
|
|
—
|
|
|
0.1
|
|
|
4.0
|
|
|||||
Sales reserve accounts:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Fiscal year ended December 28, 2018
|
|
$
|
376.6
|
|
|
$
|
2,387.5
|
|
|
$
|
—
|
|
|
$
|
(2,358.7
|
)
|
|
$
|
405.4
|
|
Fiscal year ended December 29, 2017
|
|
391.3
|
|
|
2,008.5
|
|
|
—
|
|
|
(2,023.2
|
)
|
|
376.6
|
|
|||||
Three months ended December 30, 2016
|
|
378.0
|
|
|
515.3
|
|
|
—
|
|
|
(502.0
|
)
|
|
391.3
|
|
|||||
Fiscal year ended September 30, 2016
|
|
396.4
|
|
|
2,030.8
|
|
|
—
|
|
|
(2,049.2
|
)
|
|
378.0
|
|
|||||
Tax valuation allowance:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Fiscal year ended December 28, 2018
|
|
$
|
2,267.9
|
|
|
$
|
332.8
|
|
|
$
|
4.2
|
|
|
$
|
—
|
|
|
$
|
2,604.9
|
|
Fiscal year ended December 29, 2017
|
|
1,398.3
|
|
|
804.6
|
|
|
4.0
|
|
|
61.0
|
|
|
2,267.9
|
|
|||||
Three months ended December 30, 2016
|
|
564.9
|
|
|
833.4
|
|
|
—
|
|
|
—
|
|
|
1,398.3
|
|
|||||
Fiscal year ended September 30, 2016
|
|
233.0
|
|
|
315.7
|
|
|
15.8
|
|
|
0.4
|
|
|
564.9
|
|
3)
|
Exhibits. The exhibits are included in the Exhibit Index that appears at the end of this Annual Report on Form 10-K.
|
Item 16.
|
Form 10-K Summary.
|
|
MALLINCKRODT PUBLIC LIMITED COMPANY
|
|
|
|
|
February 26, 2019
|
By:
|
/s/ George A. Kegler
|
|
|
George A. Kegler
Executive Vice President and Chief Financial Officer, Interim
(principal financial officer)
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ Mark C. Trudeau
|
|
President, Chief Executive Officer and Director
|
|
February 26, 2019
|
Mark C. Trudeau
|
|
(principal executive officer)
|
|
|
|
|
|
|
|
/s/ George A. Kegler
|
|
Executive Vice President and Chief Financial Officer, Interim
|
|
February 26, 2019
|
George A. Kegler
|
|
(principal financial officer)
|
|
|
|
|
|
|
|
/s/ Kathleen A. Schaefer
|
|
Senior Vice President, Finance and Corporate Controller
|
|
February 26, 2019
|
Kathleen A. Schaefer
|
|
(principal accounting officer)
|
|
|
|
|
|
|
|
/s/ Angus C. Russell
|
|
Chairman of the Board of Directors
|
|
February 26, 2019
|
Angus C. Russell
|
|
|
|
|
|
|
|
|
|
/s/ David R. Carlucci
|
|
Director
|
|
February 26, 2019
|
David R. Carlucci
|
|
|
|
|
|
|
|
|
|
/s/ J. Martin Carroll
|
|
Director
|
|
February 26, 2019
|
J. Martin Carroll
|
|
|
|
|
|
|
|
|
|
/s/ Paul R. Carter
|
|
Director
|
|
February 26, 2019
|
Paul R. Carter
|
|
|
|
|
|
|
|
|
|
/s/ David Y. Norton
|
|
Director
|
|
February 26, 2019
|
David Y. Norton
|
|
|
|
|
|
|
|
|
|
/s/ JoAnn A. Reed
|
|
Director
|
|
February 26, 2019
|
JoAnn A. Reed
|
|
|
|
|
|
|
|
|
|
/s/ Anne C. Whitaker
|
|
Director
|
|
February 26, 2019
|
Anne C. Whitaker
|
|
|
|
|
|
|
|
|
|
/s/ Kneeland C. Youngblood, M.D.
|
|
Director
|
|
February 26, 2019
|
Kneeland C. Youngblood, M.D.
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/s/ Joseph A. Zaccagnino
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Director
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February 26, 2019
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Joseph A. Zaccagnino
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Exhibit
Number
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Exhibit
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2.1
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2.2
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2.3
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2.4
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3.1
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3.2
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4.1
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4.2
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4.3
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4.4
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4.5
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10.1
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10.2
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10.3
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10.4
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10.5
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10.6
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10.7
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10.8
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10.9
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10.10
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10.11
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10.12
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10.13
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10.14
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10.15
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10.16
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10.17*
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10.18*
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10.19*
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10.20*
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10.21*
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10.22*
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10.23*
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10.24*
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10.25*
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10.26*
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21.1
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23.1
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31.1
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31.2
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32.1
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101
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The following materials from the Mallinckrodt plc Annual Report on Form 10-K for the fiscal year ended December 28, 2018 formatted in Extensible Business Reporting Language (XBRL): (i) the Consolidated Statements of Income, (ii) the Consolidated Statements of Comprehensive Income, (iii) the Consolidated Balance Sheets, (iv) the Consolidated Statements of Cash Flows, (v) the Consolidated Statements of Shareholders' Equity and (vi) related notes. The instance document does not appear in the interactive data file because its XBRL tags are embedded within the inline XBRL document.
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(i)
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MALLINCKRODT SECURITIZATION S.À R.L., a private limited liability company (société à responsabilité limitée) incorporated and existing under the laws of Luxembourg with its registered office at 124 Boulevard de la Petrusse, L-2330, Luxembourg, Grand Duchy of Luxembourg, and registered with the Luxembourg trade and companies register under number B 188808, as Issuer;
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(ii)
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MALLINCKRODT LLC, as Servicer;
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(iii)
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MIZUHO BANK, LTD., as a Purchaser;
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(iv)
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WELLS FARGO BANK, N.A., as a Purchaser; and
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(v)
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PNC BANK, NATIONAL ASSOCIATION, as a Purchaser and as Administrative Agent.
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MALLINCKRODT SECURITIZATION S.À R.L.
By:______________________________________
Name:
Title:
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By:______________________________________
Name:
Title:
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MALLINCKRODT LLC,
as the Servicer
By:______________________________________
Name:
Title:
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PNC BANK, NATIONAL ASSOCIATION,
as Administrative Agent
By:______________________________________
Name:
Title:
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PNC BANK, NATIONAL ASSOCIATION,
as a Purchaser
By:______________________________________
Name:
Title:
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MIZUHO BANK, LTD.,
as a Purchaser
By:______________________________________
Name:
Title:
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WELLS FARGO BANK, N.A.,
as a Purchaser
By:______________________________________
Name:
Title:
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Name of Subsidiary
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Jurisdiction of Formation
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101610 P.E.I., Inc.
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Prince Edward Island
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Acthar IP Unlimited Company
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Ireland
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BioVectra Inc.
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Prince Edward Island
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Cache Holdings Limited
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Bermuda
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Carnforth Limited
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Bermuda
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Dritte CORSA Verwaltungsgesellschaft GmbH
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Germany
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Ikaria Australia Pty Ltd
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Australia
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Ikaria Canada Inc.
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Canada
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IMC Exploration Company
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Maryland
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Infacare Pharmaceutical Corporation
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Delaware
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INO Therapeutics LLC
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Delaware
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Ludlow Corporation
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Massachusetts
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MAK LLC
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Delaware
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Mallinckrodt APAP LLC
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Delaware
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Mallinckrodt ARD Finance LLC
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Delaware
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Mallinckrodt ARD Holdings Inc.
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Delaware
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Mallinckrodt ARD Holdings Limited
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United Kingdom
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Mallinckrodt ARD Inc.
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California
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Mallinckrodt ARD IP Limited
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Ireland
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Mallinckrodt Brand Pharmaceuticals, Inc.
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Delaware
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Mallinckrodt Buckingham Unlimited Company
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Ireland
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Mallinckrodt Canada Cooperatie U.A.
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Netherlands
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Mallinckrodt Canada ULC
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Alberta
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Mallinckrodt CB LLC
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Delaware
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Mallinckrodt Chemical Holdings (U.K.) Ltd.
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United Kingdom
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Mallinckrodt Chemical Limited
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United Kingdom
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Mallinckrodt Critical Care Finance LLC
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Delaware
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Mallinckrodt Enterprises Holdings, Inc.
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California
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Mallinckrodt Enterprises LLC
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Delaware
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Mallinckrodt Enterprises UK Limited
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United Kingdom
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Mallinckrodt Equinox Finance Inc.
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Delaware
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Mallinckrodt Equinox Limited
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United Kingdom
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Mallinckrodt Finance GmbH
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Switzerland
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Mallinckrodt Finance Management Ireland Limited
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Ireland
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Mallinckrodt Group Sarl
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Luxembourg
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Mallinckrodt Group Sarl, Luxembourg (LU) Schaffhausen Branch
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Switzerland
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Mallinckrodt Holdings GmbH
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Switzerland
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Mallinckrodt Hospital Products Inc.
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Delaware
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Mallinckrodt Hospital Products IP Limited
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Ireland
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Mallinckrodt Inc.
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Delaware
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Mallinckrodt International Finance SA
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Luxembourg
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Mallinckrodt International Holdings S.a r.l.
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Luxembourg
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Mallinckrodt IP Unlimited Company
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Ireland
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Mallinckrodt LLC
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Delaware
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Mallinckrodt Lux IP S.a r.l.
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Luxembourg
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Mallinckrodt Manufacturing LLC
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Delaware
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Mallinckrodt Medical Holdings (UK) Limited
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United Kingdom
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Mallinckrodt Medical Holdings (UK) Limited (UK) Zweigniederlassung Deutschland (German Branch)
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Germany
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Mallinckrodt PEI Inc
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Quebec
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Mallinckrodt Petten Holdings B.V.
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Netherlands
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Mallinckrodt Pharma IP Trading Designated Activity Company
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Ireland
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Mallinckrodt Pharma K.K.
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Japan
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Mallinckrodt Pharmaceuticals Ireland Limited
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Ireland
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Mallinckrodt Pharmaceuticals Limited
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United Kingdom
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Mallinckrodt Quincy S.a r.l.
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Luxembourg
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Mallinckrodt Radioisotopes B.V.
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Netherlands
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Mallinckrodt SAG Holdings GmbH
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Switzerland
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Mallinckrodt Securitization Sarl
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Luxembourg
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Mallinckrodt Specialty Pharmaceuticals Ireland Limited
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Ireland
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Mallinckrodt UK Finance LLP
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United Kingdom
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Mallinckrodt UK Ltd
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United Kingdom
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Mallinckrodt US Holdings Inc.
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Nevada
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Mallinckrodt US Holdings LLC
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Delaware
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Mallinckrodt US Pool LLC
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Nevada
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Mallinckrodt Veterinary, Inc.
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Delaware
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Mallinckrodt Windsor Ireland Finance Unlimited Company
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Ireland
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Mallinckrodt Windsor Sarl
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Luxembourg
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MCCH, Inc.
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Delaware
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MEH, Inc.
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Nevada
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MHP Finance, Inc.
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Delaware
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MKG Medical UK Ltd
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United Kingdom
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Montjeu Limited
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Ireland
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MUSHI UK Holdings Limited
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United Kingdom
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OCERA Therapeutics, Inc.
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Delaware
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Petten Holdings Inc.
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Delaware
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Phoenixglade Limited
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Ireland
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Profibrix B.V.
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Netherlands
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Questcor International Ltd.
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Ireland
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SpecGx LLC
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Delaware
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Stratatech Corporation
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Delaware
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Sucampo Acquisitions GmbH
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Switzerland
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Sucampo AG
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Switzerland
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Sucampo Pharma Americas LLC
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Delaware
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Sucampo Pharma, LLC
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Japan
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Sucampo Pharmaceuticals, Inc.
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Delaware
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Sucampo, LLC
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Delaware
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Therakos (Belgium) SPRL
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Belgium
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Therakos (Canada) Company
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Nova Scotia
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Therakos (France) SAS
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France
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Therakos (Italia) S.r.l
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Italy
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Therakos (UK), Limited Dutch Branch
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Netherlands
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Therakos (UK), Limited, Sucursal en Espana
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Spain
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Therakos (UK), Ltd
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United Kingdom
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Therakos (UK), Ltd Sweden Filial
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Sweden
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Therakos (UK), Limited, Private Ltd. Liability Co. Branch
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Poland
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Therakos Europe Limited
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Ireland
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Therakos Germany GmbH
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Germany
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Therakos, Inc.
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Florida
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Vtesse Inc
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Delaware
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1.
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I have reviewed this annual report on Form 10-K of Mallinckrodt plc;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in the Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:
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a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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Date: February 26, 2019
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By:
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/s/ Mark C. Trudeau
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Mark C. Trudeau
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President and Chief Executive Officer and Director
(principal executive officer)
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1.
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I have reviewed this annual report on Form 10-K of Mallinckrodt plc;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in the Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and we have:
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a)
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b)
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c)
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Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d)
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Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
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5.
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The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
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a)
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
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b)
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
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Date: February 26, 2019
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By:
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/s/ George A. Kegler
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George A. Kegler
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Executive Vice President and Chief Financial Officer, Interim
(principal financial officer)
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By:
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/s/ Mark C. Trudeau
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Mark C. Trudeau
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President and Chief Executive Officer and Director
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By:
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/s/ George A. Kegler
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George A. Kegler
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Executive Vice President and Chief Financial Officer, Interim
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